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Clamping the Double Lumen Tube

Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03508050
Acronym
C-TDL
Enrollment
37
Registered
2018-04-25
Start date
2017-09-29
Completion date
2018-01-12
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One-lung Ventilation

Brief summary

Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it. The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air. The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded. This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).

Detailed description

One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated. Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening. A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas. Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group. Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded. The hypothesis is that by withholding gas exchange between the NVL and ambient air from the beginning of OLV to the pleural opening, the resorption atelectasis will be facilitated. Consequently, lung collapse of the NVL will occur faster when clamping its specific lumen on the DLT instead of letting it communicate with ambient air like anesthesiologists usually do.

Interventions

DEVICEClamping the Double Lumen Tube

Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

Sponsors

Jean Bussières
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Just before induction of anesthesia and according to the computerized randomization list generated by the statistical department, each of the 30 patients is allocated to one of the following groups: Control group : OLV with the specific lumen of the NVL opened to ambient air. Experimental group : OLV with a clamp on the specific lumen of the NVL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV. * More than 18 years old. * Having read, understand and signed the consent form presented at the pre-operative evaluation

Exclusion criteria

: A- Pre-operative 1. Known or anticipated difficult tracheal intubation. 2. Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT. 3. Severe COPD or asthma (FEV1 \<50%). 4. Prior intrathoracic surgery (including cardiac surgeries). 5. Pleural or interstitial pathology. 6. Previous chemotherapy or thoracic radiotherapy. 7. Acute or chronic pulmonary infection. 8. Endobronchial mass. 9. Tracheostomy. B- Post-randomisation 1. Bronchoscopic findings contraindicating the insertion of DLT. 2. VATS findings that cancel the surgery. 3. Severe desaturation (SatO2 \< 90%) during the observation period. 4. Any need to reinflate the collapse lung.

Design outcomes

Primary

MeasureTime frameDescription
T50-3From the beginning of surgery (pleural opening) until 120 minutesMoment where the probability of having a complete lung collapse is 50%

Secondary

MeasureTime frameDescription
O2 Concentration of Expired Air at Pleural OpeningFrom pleural opening and lasting 60 secondsA measure of the O2 concentration of the expiratory air at pleural opening
Expiratory Volume at Pleural OpeningFrom pleural opening and lasting 60 secondsA measure of the expiratory volume (EV) at pleural opening
O2 Concentration of Expired Air at the Beginning of One-lung VentilationFrom 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)
Optimization of Lung CollapseFrom the beginning of surgery (pleural opening) until 60 minutesNumber of Participants needing Other Interventions to Optimize Lung Collapse
Quality of Oxygenation During One-lung Ventilation (PaO2 )25 minutes after pleural openingAn evaluation of the PaO2 during one-lung ventilation
Complete Lung Collapse (CLC-clinical)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
Surgery DurationFrom the beginning of surgery (pleural opening) until 120 minutesTime required for completion of the surgery
Postoperative AtelectasisEnd of hospitalizationNumber of atelectasis detected by Postoperative X-Ray
Quality of Lung Collapse (Clinical) at 0 MinuteAt 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
Quality of Lung Collapse (Clinical) at 10 Minutes10 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
Quality of Lung Collapse (Clinical) at 20 Minutes20 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
Quality of Oxygenation During One-lung Ventilation (SaO2)25 minutes after pleural openingAn evaluation of the SaO2during one-lung ventilation

Countries

Canada

Participant flow

Participants by arm

ArmCount
Experimental
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
15
Control
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyMucus plug10
Overall StudyNegative biopsy, surgery cancelled31
Overall StudyPleural adhesions10
Overall StudySustained desaturation01

Baseline characteristics

CharacteristicTotalExperimentalControl
Age, Continuous65.6 years
STANDARD_DEVIATION 8.1
64.67 years
STANDARD_DEVIATION 9.6
66.60 years
STANDARD_DEVIATION 6.5
Forced Expiratory Volume - 1 sec (FEV1)94.77 % predicted value
STANDARD_DEVIATION 15.5
93.27 % predicted value
STANDARD_DEVIATION 15.29
96.27 % predicted value
STANDARD_DEVIATION 16.1
Height (meter)1.62 meter
STANDARD_DEVIATION 0.09
1.64 meter
STANDARD_DEVIATION 0.1
1.62 meter
STANDARD_DEVIATION 0.08
Ideal body weight (kg)58.43 kg
STANDARD_DEVIATION 6.74
59.27 kg
STANDARD_DEVIATION 7.31
57.6 kg
STANDARD_DEVIATION 6.25
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
30 Participants15 Participants15 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
22 Participants10 Participants12 Participants
Sex: Female, Male
Male
8 Participants5 Participants3 Participants
Tiffeneau index (FEV1/FVC ratio)72.63 ratio of predicted value
STANDARD_DEVIATION 8.45
71.93 ratio of predicted value
STANDARD_DEVIATION 10.29
73.33 ratio of predicted value
STANDARD_DEVIATION 6.4
Weight (kg)71.07 kg
STANDARD_DEVIATION 16.56
67.73 kg
STANDARD_DEVIATION 17.96
74.4 kg
STANDARD_DEVIATION 14.88

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
1 / 157 / 15
serious
Total, serious adverse events
0 / 201 / 17

Outcome results

Primary

T50-3

Moment where the probability of having a complete lung collapse is 50%

Time frame: From the beginning of surgery (pleural opening) until 120 minutes

ArmMeasureGroupValue (MEAN)Dispersion
Double Lumen Tube ClampT50-3First random videoclip analysis31.87 minutesStandard Deviation 3.68
Double Lumen Tube ClampT50-3Second random videoclip analysis33.30 minutesStandard Deviation 3.71
ControlT50-3First random videoclip analysis63.81 minutesStandard Deviation 10.77
ControlT50-3Second random videoclip analysis60.82 minutesStandard Deviation 7.51
Secondary

Complete Lung Collapse (CLC-clinical)

The time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery

Time frame: From the beginning of surgery (pleural opening) until 60 minutes

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampComplete Lung Collapse (CLC-clinical)28.67 minutesStandard Deviation 15.04
ControlComplete Lung Collapse (CLC-clinical)59.47 minutesStandard Deviation 20.79
Secondary

Expiratory Volume at Pleural Opening

A measure of the expiratory volume (EV) at pleural opening

Time frame: From pleural opening and lasting 60 seconds

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampExpiratory Volume at Pleural Opening178.53 mlStandard Deviation 138.12
ControlExpiratory Volume at Pleural Opening421.13 mlStandard Deviation 199.9
Secondary

O2 Concentration of Expired Air at Pleural Opening

A measure of the O2 concentration of the expiratory air at pleural opening

Time frame: From pleural opening and lasting 60 seconds

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampO2 Concentration of Expired Air at Pleural Opening41.87 % of oxygenStandard Deviation 18.61
ControlO2 Concentration of Expired Air at Pleural Opening11.93 % of oxygenStandard Deviation 3.65
Secondary

O2 Concentration of Expired Air at the Beginning of One-lung Ventilation

A measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)

Time frame: From the beginning of one-lung ventilation and lasting 60 seconds

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampO2 Concentration of Expired Air at the Beginning of One-lung Ventilation40.93 % of oxygenStandard Deviation 5.87
ControlO2 Concentration of Expired Air at the Beginning of One-lung Ventilation35.13 % of oxygenStandard Deviation 3.89
Secondary

Optimization of Lung Collapse

Number of Participants needing Other Interventions to Optimize Lung Collapse

Time frame: From the beginning of surgery (pleural opening) until 60 minutes

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Double Lumen Tube ClampOptimization of Lung Collapse0 Participants
ControlOptimization of Lung Collapse1 Participants
Secondary

Postoperative Atelectasis

Number of atelectasis detected by Postoperative X-Ray

Time frame: End of hospitalization

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Double Lumen Tube ClampPostoperative Atelectasis1 Participants
ControlPostoperative Atelectasis6 Participants
Secondary

Quality of Lung Collapse (Clinical) at 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

Time frame: At pleural opening (0 minute)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 0 MinuteNo lung collapse0 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 0 MinutePartial lung collapse14 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 0 MinuteComplete lung collapse1 Participants
ControlQuality of Lung Collapse (Clinical) at 0 MinuteNo lung collapse1 Participants
ControlQuality of Lung Collapse (Clinical) at 0 MinutePartial lung collapse14 Participants
ControlQuality of Lung Collapse (Clinical) at 0 MinuteComplete lung collapse0 Participants
Secondary

Quality of Lung Collapse (Clinical) at 10 Minutes

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

Time frame: 10 minutes after pleural opening

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 10 MinutesNo lung collapse1 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 10 MinutesPartial lung collapse14 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 10 MinutesComplete lung collapse0 Participants
ControlQuality of Lung Collapse (Clinical) at 10 MinutesNo lung collapse0 Participants
ControlQuality of Lung Collapse (Clinical) at 10 MinutesPartial lung collapse14 Participants
ControlQuality of Lung Collapse (Clinical) at 10 MinutesComplete lung collapse1 Participants
Secondary

Quality of Lung Collapse (Clinical) at 20 Minutes

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

Time frame: 20 minutes after pleural opening

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 20 MinutesNo lung collapse0 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 20 MinutesPartial lung collapse8 Participants
Double Lumen Tube ClampQuality of Lung Collapse (Clinical) at 20 MinutesComplete lung collapse7 Participants
ControlQuality of Lung Collapse (Clinical) at 20 MinutesNo lung collapse0 Participants
ControlQuality of Lung Collapse (Clinical) at 20 MinutesPartial lung collapse14 Participants
ControlQuality of Lung Collapse (Clinical) at 20 MinutesComplete lung collapse1 Participants
Secondary

Quality of Oxygenation During One-lung Ventilation (PaO2 )

An evaluation of the PaO2 during one-lung ventilation

Time frame: 25 minutes after pleural opening

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampQuality of Oxygenation During One-lung Ventilation (PaO2 )162.86 mmHgStandard Deviation 68.71
ControlQuality of Oxygenation During One-lung Ventilation (PaO2 )128.60 mmHgStandard Deviation 57.69
Secondary

Quality of Oxygenation During One-lung Ventilation (SaO2)

An evaluation of the SaO2during one-lung ventilation

Time frame: 25 minutes after pleural opening

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampQuality of Oxygenation During One-lung Ventilation (SaO2)97.78 % of oxygen saturationStandard Deviation 1.79
ControlQuality of Oxygenation During One-lung Ventilation (SaO2)95.67 % of oxygen saturationStandard Deviation 2.09
Secondary

Surgery Duration

Time required for completion of the surgery

Time frame: From the beginning of surgery (pleural opening) until 120 minutes

ArmMeasureValue (MEAN)Dispersion
Double Lumen Tube ClampSurgery Duration89.27 minutesStandard Deviation 34.01
ControlSurgery Duration88.40 minutesStandard Deviation 30.39

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026