Trial Outcomes & Findings for Double-lumen Tubes (DLT) - Health Economic Study (NCT NCT03817879)

NCT ID: NCT03817879

Last Updated: 2020-02-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: During procedure, up to 4 hours
• Results posted on: 2020-02-13

Participant Flow

Participant milestones

Measure	VivaSight Double-lumen Tube VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera	Conventional Double-lumen Tube Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
Overall Study STARTED	35	35
Overall Study COMPLETED	30	22
Overall Study NOT COMPLETED	5	13

Reasons for withdrawal

Measure	VivaSight Double-lumen Tube VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera	Conventional Double-lumen Tube Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
Overall Study Drop out	5	12
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	VivaSight Double-lumen Tube n=30 Participants VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera	Conventional Double-lumen Tube n=22 Participants Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera	Total n=52 Participants Total of all reporting groups
Age, Continuous	65.80 years STANDARD_DEVIATION 10.02 • n=30 Participants	68.50 years STANDARD_DEVIATION 7.16 • n=22 Participants	66.94 years STANDARD_DEVIATION 8.94 • n=52 Participants
Sex: Female, Male Female	13 Participants n=30 Participants	12 Participants n=22 Participants	25 Participants n=52 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	10 Participants n=22 Participants	27 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	172.47 cm STANDARD_DEVIATION 9.32 • n=30 Participants	172.77 cm STANDARD_DEVIATION 9.56 • n=22 Participants	172.60 cm STANDARD_DEVIATION 9.33 • n=52 Participants
Weight	74.73 kg STANDARD_DEVIATION 19.14 • n=30 Participants	76.23 kg STANDARD_DEVIATION 17.12 • n=22 Participants	75.37 kg STANDARD_DEVIATION 18.15 • n=52 Participants
Surgical lung Left	9 Participants n=30 Participants	4 Participants n=22 Participants	13 Participants n=52 Participants
Surgical lung Right	21 Participants n=30 Participants	18 Participants n=22 Participants	39 Participants n=52 Participants

PRIMARY outcome

Timeframe: During procedure, up to 4 hours

Outcome measures

Measure	VivaSight Double-lumen Tube n=30 Participants VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera	Conventional Double-lumen Tube n=22 Participants Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
Number of Times Bronchoscope is Used	0.07 Reported uses of bronchoscopes Standard Deviation 0.25	3.14 Reported uses of bronchoscopes Standard Deviation 1.58

SECONDARY outcome

Timeframe: During procedure, up to 4 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During procedure, up to 4 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During procedure, up to 4 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During procedure, up to 4 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: An average of 1 year

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure, up to 4 hours

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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 48 hours after the procedure

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)

Outcome measures

Outcome data not reported

Adverse Events

VivaSight Double-lumen Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Double-lumen Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Charlotte Lundgaard

Ambu A/S

Phone: +4529643748

Email: aclu@ambu.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place