## Protocol Section
### Identification Module
**NCT ID:** NCT02376179

**Brief Title:** Endotracheal Tube Intracuff Pressure and Leak

**Official Title:** Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy

#### Organization Study ID Info
**ID:** IRB13-00613
#### Organization
**Class:** OTHER
**Full Name:** Nationwide Children's Hospital
### Status Module
#### Completion Date
**Date:** 2016-06-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-11

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-06-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-01-16

**Type:** ACTUAL

**Results First Submit Date:** 2018-07-24

**Results First Submit QC Date:** 2018-07-24

#### Start Date
**Date:** 2014-08

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2015-03-03
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-24
**Study First Submit QC Date:** 2015-02-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kris Jatana

#### Responsible Party

**Investigator Affiliation:** Nationwide Children's Hospital

**Investigator Full Name:** Kris Jatana

**Investigator Title:** ENT Surgeon

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.

### Conditions Module

**Conditions:**

- Otolaryngological Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 84

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.

**Intervention Names:**

- Device: Cuffed ETT

**Label:** Cuffed ETT

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cuffed ETT

**Name:** Cuffed ETT

**Other Names:**

- Kimberly Clark Microcuff ETT

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.

**Measure:** Changes in the Intracuff Pressure

**Time Frame:** during time of surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube.
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

**Maximum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbus

**Country:** United States

**Facility:** Nationwide Children's Hospital

**State:** Ohio

**Zip:** 43205

### References Module

#### References

**Citation:** Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9.

**PMID:** 26956620

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Cuffed ETT

**Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.

**ID:** EG000

**Other Num at Risk:** 84

**Serious Number At Risk:** 84

**Title:** Cuffed ETT

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 84

**Units:** Participants

### Group

**ID:** BG000

**Title:** Cuffed ETT

**Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.

Cuffed ETT

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 84

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.9

**Value:** 5.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 46

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 38

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 84

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Kris.Jatana@nationwidechildrens.org
**Organization:** Nationwide Children's Hospital
**Phone:** 614-722-6032
**Title:** Kris Jatana, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7
- **Upper Limit:** 
- **Value:** 3
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** during time of surgery
**Title:** Changes in the Intracuff Pressure
**Type:** PRIMARY
**Unit of Measure:** cmH2O
##### Group
**Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.

Cuffed ETT
**ID:** OG000
**Title:** Cuffed ETT
### Participant Flow Module
#### Group
**Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
**ID:** FG000
**Title:** Cuffed ETT
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 84
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 84
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True