Trial Outcomes & Findings for Clamping the Double Lumen Tube (NCT NCT03508050)
NCT ID: NCT03508050
Last Updated: 2020-04-27
Results Overview
Moment where the probability of having a complete lung collapse is 50%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
From the beginning of surgery (pleural opening) until 120 minutes
Results posted on
2020-04-27
Participant Flow
Participant milestones
| Measure |
Double Lumen Tube Clamp
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Double Lumen Tube Clamp
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Overall Study
Pleural adhesions
|
1
|
0
|
|
Overall Study
Mucus plug
|
1
|
0
|
|
Overall Study
Negative biopsy, surgery cancelled
|
3
|
1
|
|
Overall Study
Sustained desaturation
|
0
|
1
|
Baseline Characteristics
Clamping the Double Lumen Tube
Baseline characteristics by cohort
| Measure |
Experimental
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.67 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66.60 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Height (meter)
|
1.64 meter
STANDARD_DEVIATION 0.10 • n=5 Participants
|
1.62 meter
STANDARD_DEVIATION 0.08 • n=7 Participants
|
1.62 meter
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Weight (kg)
|
67.73 kg
STANDARD_DEVIATION 17.96 • n=5 Participants
|
74.4 kg
STANDARD_DEVIATION 14.88 • n=7 Participants
|
71.07 kg
STANDARD_DEVIATION 16.56 • n=5 Participants
|
|
Ideal body weight (kg)
|
59.27 kg
STANDARD_DEVIATION 7.31 • n=5 Participants
|
57.6 kg
STANDARD_DEVIATION 6.25 • n=7 Participants
|
58.43 kg
STANDARD_DEVIATION 6.74 • n=5 Participants
|
|
Forced Expiratory Volume - 1 sec (FEV1)
|
93.27 % predicted value
STANDARD_DEVIATION 15.29 • n=5 Participants
|
96.27 % predicted value
STANDARD_DEVIATION 16.1 • n=7 Participants
|
94.77 % predicted value
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Tiffeneau index (FEV1/FVC ratio)
|
71.93 ratio of predicted value
STANDARD_DEVIATION 10.29 • n=5 Participants
|
73.33 ratio of predicted value
STANDARD_DEVIATION 6.4 • n=7 Participants
|
72.63 ratio of predicted value
STANDARD_DEVIATION 8.45 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the beginning of surgery (pleural opening) until 120 minutesMoment where the probability of having a complete lung collapse is 50%
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=14 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
T50-3
First random videoclip analysis
|
31.87 minutes
Standard Deviation 3.68
|
63.81 minutes
Standard Deviation 10.77
|
|
T50-3
Second random videoclip analysis
|
33.30 minutes
Standard Deviation 3.71
|
60.82 minutes
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: From the beginning of surgery (pleural opening) until 60 minutesThe time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Complete Lung Collapse (CLC-clinical)
|
28.67 minutes
Standard Deviation 15.04
|
59.47 minutes
Standard Deviation 20.79
|
SECONDARY outcome
Timeframe: From pleural opening and lasting 60 secondsA measure of the O2 concentration of the expiratory air at pleural opening
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
O2 Concentration of Expired Air at Pleural Opening
|
41.87 % of oxygen
Standard Deviation 18.61
|
11.93 % of oxygen
Standard Deviation 3.65
|
SECONDARY outcome
Timeframe: From pleural opening and lasting 60 secondsA measure of the expiratory volume (EV) at pleural opening
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Expiratory Volume at Pleural Opening
|
178.53 ml
Standard Deviation 138.12
|
421.13 ml
Standard Deviation 199.9
|
SECONDARY outcome
Timeframe: From the beginning of one-lung ventilation and lasting 60 secondsA measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
O2 Concentration of Expired Air at the Beginning of One-lung Ventilation
|
40.93 % of oxygen
Standard Deviation 5.87
|
35.13 % of oxygen
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: From the beginning of surgery (pleural opening) until 60 minutesNumber of Participants needing Other Interventions to Optimize Lung Collapse
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Optimization of Lung Collapse
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 25 minutes after pleural openingAn evaluation of the PaO2 during one-lung ventilation
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=14 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Quality of Oxygenation During One-lung Ventilation (PaO2 )
|
162.86 mmHg
Standard Deviation 68.71
|
128.60 mmHg
Standard Deviation 57.69
|
SECONDARY outcome
Timeframe: 25 minutes after pleural openingAn evaluation of the SaO2during one-lung ventilation
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=14 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Quality of Oxygenation During One-lung Ventilation (SaO2)
|
97.78 % of oxygen saturation
Standard Deviation 1.79
|
95.67 % of oxygen saturation
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: From the beginning of surgery (pleural opening) until 120 minutesTime required for completion of the surgery
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Surgery Duration
|
89.27 minutes
Standard Deviation 34.01
|
88.40 minutes
Standard Deviation 30.39
|
SECONDARY outcome
Timeframe: End of hospitalizationNumber of atelectasis detected by Postoperative X-Ray
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Postoperative Atelectasis
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At pleural opening (0 minute)A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Quality of Lung Collapse (Clinical) at 0 Minute
No lung collapse
|
0 Participants
|
1 Participants
|
|
Quality of Lung Collapse (Clinical) at 0 Minute
Partial lung collapse
|
14 Participants
|
14 Participants
|
|
Quality of Lung Collapse (Clinical) at 0 Minute
Complete lung collapse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 minutes after pleural openingA clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Quality of Lung Collapse (Clinical) at 10 Minutes
No lung collapse
|
1 Participants
|
0 Participants
|
|
Quality of Lung Collapse (Clinical) at 10 Minutes
Partial lung collapse
|
14 Participants
|
14 Participants
|
|
Quality of Lung Collapse (Clinical) at 10 Minutes
Complete lung collapse
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 20 minutes after pleural openingA clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Outcome measures
| Measure |
Double Lumen Tube Clamp
n=15 Participants
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 Participants
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Quality of Lung Collapse (Clinical) at 20 Minutes
No lung collapse
|
0 Participants
|
0 Participants
|
|
Quality of Lung Collapse (Clinical) at 20 Minutes
Partial lung collapse
|
8 Participants
|
14 Participants
|
|
Quality of Lung Collapse (Clinical) at 20 Minutes
Complete lung collapse
|
7 Participants
|
1 Participants
|
Adverse Events
Double Lumen Tube Clamp
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double Lumen Tube Clamp
n=15 participants at risk；n=20 participants at risk
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 participants at risk；n=17 participants at risk
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Desaturation
|
0.00%
0/20 • Adverse event data were collected from the beginning of the surgery through completion of surgery. Moreover, the first PACU thoracic x-ray of each patient was analyzed by a radiologist in order to detect anomalies.
|
5.9%
1/17 • Adverse event data were collected from the beginning of the surgery through completion of surgery. Moreover, the first PACU thoracic x-ray of each patient was analyzed by a radiologist in order to detect anomalies.
|
Other adverse events
| Measure |
Double Lumen Tube Clamp
n=15 participants at risk；n=20 participants at risk
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
Control
n=15 participants at risk；n=17 participants at risk
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
X-ray anomalies
|
6.7%
1/15 • Adverse event data were collected from the beginning of the surgery through completion of surgery. Moreover, the first PACU thoracic x-ray of each patient was analyzed by a radiologist in order to detect anomalies.
|
46.7%
7/15 • Adverse event data were collected from the beginning of the surgery through completion of surgery. Moreover, the first PACU thoracic x-ray of each patient was analyzed by a radiologist in order to detect anomalies.
|
Additional Information
Dr Jean S. Bussières
Institut universitaire de cardiologie et de pneumologie de Québec
Phone: 418-656-8711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place