## Protocol Section
### Identification Module
**NCT ID:** NCT03091179

**Brief Title:** Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery

**Official Title:** The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical Procedures.

#### Organization Study ID Info
**ID:** 39202
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
### Status Module
#### Completion Date
**Date:** 2018-07-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-04

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-07-18

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-07-17

**Type:** ACTUAL

**Results First Submit Date:** 2019-06-21

**Results First Submit QC Date:** 2019-06-21

#### Start Date
**Date:** 2017-03-17

**Type:** ACTUAL

**Status Verified Date:** 2020-02

#### Study First Post Date
**Date:** 2017-03-27
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-05
**Study First Submit QC Date:** 2017-03-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** Vladimir Nekhendzy

**Investigator Title:** Clinical Professor of Anesthesiology and Otolaryngology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

### Conditions Module

**Conditions:**

- Laryngologic Surgical Procedures

**Keywords:**

- airway management

- high flow nasal oxygen

- high flow nasal cannula

- THRIVE

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** high flow nasal oxygen

**Intervention Names:**

- Device: THRIVE

**Label:** THRIVE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** tracheal intubation

**Intervention Names:**

- Device: Endotracheal tube

**Label:** Endotracheal tube

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- THRIVE

**Description:** active nasal oxygen delivery system

**Name:** THRIVE

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Endotracheal tube

**Description:** a plastic tube for mechanical ventilation

**Name:** Endotracheal tube

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)

**Time Frame:** intraoperative (up to one hour)

**Description:** time from end of surgery to responding to commands/extubation

**Measure:** Time to Awakening From Anesthesia (Primary Anesthesia Outcome)

**Time Frame:** intraoperative (up to 20 min)

**Description:** Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope

**Measure:** Suspension Time (Primary Surgical Outcome)

**Time Frame:** intraoperative (up to 5 min)

**Description:** Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope

**Measure:** Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)

**Time Frame:** intraoperative (up to 5 min)

**Measure:** Duration of Surgery (Primary Surgical Outcome)

**Time Frame:** intraoperative (up to one hour)

#### Secondary Outcomes

**Description:** Time required for the patient to become fully alert and oriented per standard recovery room evaluation

**Measure:** Alertness

**Time Frame:** Recovery room admission (up to 30 min following admission to recovery room)

**Measure:** Recovery Room Time

**Time Frame:** Up to 2 hours after procedure

**Description:** A score from 0 to 10, higher scores corresponding to higher pain

**Measure:** Numerical Pain Rating Scores

**Time Frame:** Recovery room admission and discharge (up to 2 hours)

**Description:** Total oral opioid consumption in morphine milligram equivalents

**Measure:** Opioid Consumption

**Time Frame:** Recovery room admission and discharge (up to 2 hours)

**Description:** numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome

**Measure:** Change in Voice Handicap Index (VHI)

**Time Frame:** Preoperative assessment and one month after surgery

**Description:** 15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.

**Measure:** Quality of Recovery

**Time Frame:** One week after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients presenting for short, non-laser laryngologic surgery

Exclusion Criteria:

1. Patients with significantly decreased myocardial function (ejection fraction \< 50%)
2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2.
6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
8. Patients with skull base defects.
9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
10. Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 \< 95%.
11. Obese patients with BMI above 35 kg/m2.

13. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

14. Patients with hiatal hernia and full stomach patients. 15. Patient's refusal to participate in the study. 16. Patients who do not understand English or mentally handicapped. 17. Pregnant or breastfeeding patients.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford Hospital and Clinics

**State:** California

**Zip:** 94305

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Vladimir Nekhendzy, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.

**PMID:** 32078170

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-06-20

- Filename: SAP_000.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 365669

- Type Abbrev: SAP

- Upload Date: 2019-06-20T13:17

- Date: 2017-02-15

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 328212

- Type Abbrev: Prot

- Upload Date: 2019-06-21T00:46

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** THRIVE

**Deaths Num At Risk:** 10

**Description:** THRIVE: active nasal oxygen delivery system

**ID:** EG000

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** THRIVE

**Group ID:** EG001

**Title:** Control Group

**Deaths Num At Risk:** 10

**Description:** Endotracheal tube or Supraglottic jet ventilation

**ID:** EG001

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** Control Group

**Frequency Threshold:** 0

**Time Frame:** one month

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** THRIVE

**Description:** THRIVE: active nasal oxygen delivery system

### Group

**ID:** BG001

**Title:** Control Group

**Description:** Endotracheal tube or Supraglottic jet ventilation

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.42

**Value:** 50.9

#### Measurement

**Group ID:** BG001

**Spread:** 17.29

**Value:** 55.2

#### Measurement

**Group ID:** BG002

**Spread:** 14.82

**Value:** 53.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** nek@stanford.edu
**Organization:** Stanford University
**Phone:** 650-498-4055
**Title:** Vladimir Nekhendzy
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** P value was calculated using the means and standard deviations for each of the patient characteristics.
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.006
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.66
- **Upper Limit:** 
- **Value:** 93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.57
- **Upper Limit:** 
- **Value:** 98.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.0
- **Upper Limit:** 
- **Value:** 10.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.4
- **Upper Limit:** 
- **Value:** 9.4
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.1
- **Upper Limit:** 
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 4.3
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.95
- **Upper Limit:** 
- **Value:** 1.7
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.82
- **Upper Limit:** 
- **Value:** 19.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.85
- **Upper Limit:** 
- **Value:** 20.9
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.3
- **Upper Limit:** 
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.4
- **Upper Limit:** 
- **Value:** 4.8
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 43.41
- **Upper Limit:** 
- **Value:** 65.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 42.84
- **Upper Limit:** 
- **Value:** 77.7
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.95
- **Upper Limit:** 
- **Value:** 1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.91
- **Upper Limit:** 
- **Value:** 3.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.29
- **Upper Limit:** 
- **Value:** 0.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.77
- **Upper Limit:** 
- **Value:** 2.7
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.0
- **Upper Limit:** 
- **Value:** 8.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 22.1
- **Upper Limit:** 
- **Value:** 22.5
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.63
- **Upper Limit:** 
- **Value:** 12.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.06
- **Upper Limit:** 
- **Value:** 22.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.19
- **Upper Limit:** 
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.22
- **Upper Limit:** 
- **Value:** 13.6
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.7
- **Upper Limit:** 
- **Value:** 142.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 17.9
- **Upper Limit:** 
- **Value:** 131.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** intraoperative (up to one hour)
**Title:** Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
**Type:** PRIMARY
**Unit of Measure:** percentage of saturation (SpO2)
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 2
**Description:** time from end of surgery to responding to commands/extubation
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** intraoperative (up to 20 min)
**Title:** Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 3
**Description:** Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** intraoperative (up to 5 min)
**Title:** Suspension Time (Primary Surgical Outcome)
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 4
**Description:** Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** intraoperative (up to 5 min)
**Title:** Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
**Type:** PRIMARY
**Unit of Measure:** maneuvers
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** intraoperative (up to one hour)
**Title:** Duration of Surgery (Primary Surgical Outcome)
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 6
**Description:** Time required for the patient to become fully alert and oriented per standard recovery room evaluation
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Recovery room admission (up to 30 min following admission to recovery room)
**Title:** Alertness
**Type:** SECONDARY
**Unit of Measure:** minutes
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 7
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Up to 2 hours after procedure
**Title:** Recovery Room Time
**Type:** SECONDARY
**Unit of Measure:** minutes
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 8
**Description:** A score from 0 to 10, higher scores corresponding to higher pain
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Recovery room admission and discharge (up to 2 hours)
**Title:** Numerical Pain Rating Scores
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 9
**Description:** Total oral opioid consumption in morphine milligram equivalents
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Recovery room admission and discharge (up to 2 hours)
**Title:** Opioid Consumption
**Type:** SECONDARY
**Unit of Measure:** MME: morphine milligram equivalents
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 10
**Description:** numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Preoperative assessment and one month after surgery
**Title:** Change in Voice Handicap Index (VHI)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 11
**Description:** 15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** One week after surgery
**Title:** Quality of Recovery
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** OG000
**Title:** THRIVE
##### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** OG001
**Title:** Control Group
### Participant Flow Module
#### Group
**Description:** THRIVE: active nasal oxygen delivery system
**ID:** FG000
**Title:** THRIVE
#### Group
**Description:** Endotracheal tube or Supraglottic jet ventilation
**ID:** FG001
**Title:** Control Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True