## Protocol Section
### Identification Module
**NCT ID:** NCT03817879

**Brief Title:** Double-lumen Tubes (DLT) - Health Economic Study

**Official Title:** A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery

#### Organization Study ID Info
**ID:** CIS-009
#### Organization
**Class:** INDUSTRY
**Full Name:** Ambu A/S
### Status Module
#### Completion Date
**Date:** 2019-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-13

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-01-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-02-13

**Type:** ACTUAL

**Results First Submit Date:** 2019-10-14

**Results First Submit QC Date:** 2020-02-03

#### Start Date
**Date:** 2018-11-02

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2019-01-28
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-09
**Study First Submit QC Date:** 2019-01-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Ambu A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.

**Detailed Description:** A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.

The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.

### Conditions Module

**Conditions:**

- Single Lung Ventilation

- Thoracic Surgery

- Anesthesia

- Cost-effectiveness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: VivaSight double-lumen tube for single-lung ventilation

**Label:** VivaSight double-lumen tube

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Conventional double-lument tube for single-lung ventilation

**Label:** Conventional double-lumen tube

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VivaSight double-lumen tube

**Description:** Procedure using a tube with a camera

**Name:** VivaSight double-lumen tube for single-lung ventilation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Conventional double-lumen tube

**Description:** Procedure using a tube without a camera

**Name:** Conventional double-lument tube for single-lung ventilation

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)

**Measure:** Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.

**Time Frame:** During procedure, up to 4 hours

**Description:** Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)

**Measure:** Patient Reported Post Operative Outcomes

**Time Frame:** Within 48 hours after the procedure

#### Primary Outcomes

**Measure:** Number of Times Bronchoscope is Used

**Time Frame:** During procedure, up to 4 hours

#### Secondary Outcomes

**Measure:** Intubation Time

**Time Frame:** During procedure, up to 4 hours

**Measure:** Number of Intubation Attempts

**Time Frame:** During procedure, up to 4 hours

**Measure:** Number of Time the Tube Was Repositioned

**Time Frame:** During procedure, up to 4 hours

**Measure:** Number of Times Repositioning of the Tube Was Prevented

**Time Frame:** During procedure, up to 4 hours

**Measure:** Cost Per Procedure

**Time Frame:** An average of 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
* The subject or legal representative has signed the Informed Consent
* The subject is admitted at Odense University Hospital (OUH), department V
* Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
* Subjects \> 18 years of age

Exclusion Criteria:

* Subjects with known tracheobronchial anatomic anomalies
* Subjects going for emergency procedures
* Subjects with anticipated difficult airways
* Subjects with known tracheal pathology
* Subjects requiring rapid sequence induction
* Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
* Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
* Subjects requiring a right-sided DLT
* Subjects who had participated in the study before

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Odense

**Country:** Denmark

**Facility:** Odense University Hospital

**Zip:** 5000

### IPD Sharing Statement Module

**Description:** Data will described in groups

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.

**PMID:** 31297752

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-06-26

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1329803

- Type Abbrev: Prot_SAP

- Upload Date: 2020-02-03T07:03

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** VivaSight Double-lumen Tube

**Deaths Num At Risk:** 30

**Description:** VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera

**ID:** EG000

**Other Num at Risk:** 30

**Serious Number At Risk:** 30

**Title:** VivaSight Double-lumen Tube

**Group ID:** EG001

**Title:** Conventional Double-lumen Tube

**Deaths Num At Risk:** 22

**Description:** Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera

**ID:** EG001

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** Conventional Double-lumen Tube

**Frequency Threshold:** 0

**Time Frame:** Up to 48 hours post procedure.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Units:** Participants

### Group

**ID:** BG000

**Title:** VivaSight Double-lumen Tube

**Description:** VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera

### Group

**ID:** BG001

**Title:** Conventional Double-lumen Tube

**Description:** Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.02

**Value:** 65.80

#### Measurement

**Group ID:** BG001

**Spread:** 7.16

**Value:** 68.50

#### Measurement

**Group ID:** BG002

**Spread:** 8.94

**Value:** 66.94

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 25

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 27

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**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:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.32

**Value:** 172.47

#### Measurement

**Group ID:** BG001

**Spread:** 9.56

**Value:** 172.77

#### Measurement

**Group ID:** BG002

**Spread:** 9.33

**Value:** 172.60

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 19.14

**Value:** 74.73

#### Measurement

**Group ID:** BG001

**Spread:** 17.12

**Value:** 76.23

#### Measurement

**Group ID:** BG002

**Spread:** 18.15

**Value:** 75.37

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Class Title:** Left

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 39

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 52

**Class Title:** Right

**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
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height
**Unit of Measure:** cm
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** kg
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Surgical lung
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** aclu@ambu.com
**Organization:** Ambu A/S
**Phone:** +4529643748
**Title:** Anna Charlotte Lundgaard
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.07
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.58
- **Upper Limit:** 
- **Value:** 3.14
**Title:** 
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Number of Times Bronchoscope is Used
**Type:** PRIMARY
**Unit of Measure:** Reported uses of bronchoscopes
##### Group
**Description:** VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
**ID:** OG000
**Title:** VivaSight Double-lumen Tube
##### Group
**Description:** Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
**ID:** OG001
**Title:** Conventional Double-lumen Tube
#### Outcome Measure 2
**Reporting Status:** NOT_POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Intubation Time
**Type:** SECONDARY
#### Outcome Measure 3
**Reporting Status:** NOT_POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Number of Intubation Attempts
**Type:** SECONDARY
#### Outcome Measure 4
**Reporting Status:** NOT_POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Number of Time the Tube Was Repositioned
**Type:** SECONDARY
#### Outcome Measure 5
**Reporting Status:** NOT_POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Number of Times Repositioning of the Tube Was Prevented
**Type:** SECONDARY
#### Outcome Measure 6
**Reporting Status:** NOT_POSTED
**Time Frame:** An average of 1 year
**Title:** Cost Per Procedure
**Type:** SECONDARY
#### Outcome Measure 7
**Description:** Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)
**Reporting Status:** NOT_POSTED
**Time Frame:** During procedure, up to 4 hours
**Title:** Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 8
**Description:** Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)
**Reporting Status:** NOT_POSTED
**Time Frame:** Within 48 hours after the procedure
**Title:** Patient Reported Post Operative Outcomes
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
**ID:** FG000
**Title:** VivaSight Double-lumen Tube
#### Group
**Description:** Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
**ID:** FG001
**Title:** Conventional Double-lumen Tube
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Drop out
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 12
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 35
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
**Has Results:** True