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Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms

Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02919267
Acronym
PLC-OLV
Enrollment
40
Registered
2016-09-29
Start date
2016-09-30
Completion date
2016-12-31
Last updated
2020-05-26

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

Conditions

Lung Collapse, One-Lung Ventilation, Thoracic Surgery, Video-Assisted

Keywords

One lung ventilation, Lung collapse, Bronchial blocker, Double lumen tube, video assisted thoracoscopic surgery, VATS, DLT, Thoracic surgery, Video-assisted

Brief summary

Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV is not well described in the literature. Few publications characterized scant aspects of lung collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung collapse have been described. The first phase is a quick and partial secondary to the intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the alveoli by the capillary bed. The investigators plan to describe the physiology of the second phase of lung deflation using of DLT or BB, in a human clinical context.

Detailed description

Lung isolation and one-lung ventilation (OLV) have been used for more than 60 years, principally via double lumen endotracheal tubes (DLT). Since the beginning of the 21st century, modernisation of bronchial blockers (BB) has favoured their more frequent use. Meanwhile, video assisted thoracoscopic surgery (VATS) has increased, becoming the standard for the majority of intra-thoracic pulmonary surgeries. Lung collapse during OLV undergoes two distinct phases. The first phase occurs at the opening of the pleural cavity and corresponds to a quick but partial collapse of the lung due to its intrinsic recoil. This phase probably ends when small airways are closed. Thereafter, the second phase, a slower one, corresponds to the reabsorption, by the capillary bed, of gas contained into the alveoli. The speed of this reabsorption depends on the solubility of the gas contained in the alveoli. Intriguingly, the physiology of lung collapse under OLV remains poorly understood, especially with the use of BB. Theoretically, many aspects of lung isolation may influence lung collapse, including the ventilation strategy before OLV, the timing and the lung isolation devices being used. While oxygen at 100% is widely used for ventilation before OLV, the timing of initiation of lung isolation varies from centers to centers. Indeed, the most conservative will begin the lung isolation just before the opening of the pleural space, whereas others begin the lung isolation following the appropriate positioning of the patient and confirmation that the lung isolation device is properly positioned by fiberoptic bronchoscopy (FOB) examination. Therefore, the period between initiation of lung isolation and pleural opening may vary from a few minutes to \>30 minutes. The mechanic of lung isolation differs between DLT and BB and consequently the physiology of lung deflation may be different. When using DLT, the lumen that corresponds to the collapsed lung is disconnected from the ventilator and is continuously in communication with the ambient air. When using BB a bronchial cuff is inflated within the main bronchus following a 30 seconds apnea period, allowing the initial lung deflation to be mediated by elastic lung recoil. After this initial phase, the only communication with ambient air is through the small (2 mm) and long internal (67 mm) channel, which is completely different from the larger lumen of the DLT. Rapid and complete lung collapse is essential during lung isolation for VATS otherwise; there is no alternative available for the surgeon to get proper view of the pulmonary hilum. Previous studies suggested that BB allow a less effective lung collapse than the one obtained with DLT. However, the authors recently documented that the use of BB with its internal channel occluded creates a statistically significant shorter time to complete lung collapse during VATS compared to DLT (36.6 ± 29.1 vs 7.5 ± 3.8 min; p\<0.001). In contrast to the previous studies, the authors used off-line review videos recorded during the surgery to obtain a more objective evaluation of the complete lung collapse time which probably reflected the second phase of lung deflation. Although, our definition of lung collapse was very strict, meaning complete collapse of all the lung areas, graded using a standardized visual scale and chart. However, authors do not have any data to explain why this internal channel occlusion may have some positive impact. The authors hypothesized that their results could be explained by the optimisation of the reabsorption phases following enhanced atelectasis by gas reabsorption (phase 2) after bronchial blockade. This latter hypothesis is supported by a pilot observation that ambient air (FiO2 at 0.21) was sucked up within the collapsing lung when using DLT to a greater extent than with the use of BB (unpublished data). The presence of ambient air (21%) in the alveolar space may likely slowing subsequent gas reabsorption compared to intra-alveolar 100% O2 . However, these hypotheses remain to be confirmed. The investigators proposed this study to update the knowledge about lung collapse with the actual lung isolation devices: DLT and BB. This protocol will describe the lung collapse physiology and allows getting data for the elaboration of further studies. Thus the present hypothesis is that during the second phase of lung collapse, the inflow of air through the lumen of the non-ventilated lung of the DLT is greater than through the internal channel of the BB, in the course of lung isolation for OLV. The main objective of this study is the gas volume quantification (GVQ) coming from ambient air towards the alveoli space of the non-ventilated lung during OLV with the use of DLT and BB. These measurements will be performed from the beginning of OLV until 60 minutes after, meaning approximatively 45 minutes after the opening of the pleura by the surgeon. The secondary objective is the intra-pulmonary pressure measurement (IPM) in the non-ventilated lung with the use of DLT and BB during the same period.

Interventions

Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group.

Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group.

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* elective unilateral lung resection (anatomical segmentectomy, lobectomy or pneumonectomy) for lung cancer

Exclusion criteria

* anticipated difficult mask ventilation or intubation * pleural pathology * previous thoracic surgery * previous sternotomy * previous chemotherapy or chest radiotherapy * severe COPD or asthma (FEV1 ≤ 50%) * active or chronic pulmonary infection * endobronchial mass * tracheostomy Post randomisation

Design outcomes

Primary

MeasureTime frame
Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.From the beginning of OLV until 60 minutes

Secondary

MeasureTime frameDescription
Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BBFrom the beginning until 10 minutes of OLVIntra-pulmonary pressure measured from initiation of OLV to pleural opening were similarly analyzed using a two-way ANOVA. Two experimental factors, one associated to the comparison between two groups (DLT versus BB), factor fixed and one associated to the comparison among results from the time periods (0 to 10 minutes), factor fixed with interaction terms between the fixed factors were defined. The data was analyzed using a repeated mixed model. An autoregressive covariance structure was used to consider the dependency among repeated measurements.

Countries

Canada

Participant flow

Recruitment details

As mentioned into the Methods section of the protocol, each patients that were excluded after randomization were replaced by a new randomized patient. We had to randomized 49 patients in order to analyze a total of 39 patients.

Pre-assignment details

One patient was excluded after the study was completed because when we started the analysis of the results, we realized that one of the patient had an air leak during the study period that was not recognized by the investigator. Since the study was completed, we could not randomized a new patient.

Participants by arm

ArmCount
Intra-pulmonary Pressure Measurements With Double-lumen Tube
For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
10
Intra-pulmonary Pressure Determination With Bronchial Blocker
For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
9
Gas Movement Quantification With Double-lumen Tube
For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
10
Gas Movement Quantification With Bronchial Blocker
For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
10
Total39

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyProtocol Violation0334

Baseline characteristics

CharacteristicTotalIntra-pulmonary Pressure Determination With Bronchial BlockerIntra-pulmonary Pressure Measurements With Double-lumen TubeGas Movement Quantification With Double-lumen TubeGas Movement Quantification With Bronchial Blocker
Age, Continuous63 years
STANDARD_DEVIATION 11
67 years
STANDARD_DEVIATION 7
58 years
STANDARD_DEVIATION 10
64 years
STANDARD_DEVIATION 13
64 years
STANDARD_DEVIATION 13
BMI (kg/m2)27 kilograms/m^2
STANDARD_DEVIATION 6
28 kilograms/m^2
STANDARD_DEVIATION 7
28 kilograms/m^2
STANDARD_DEVIATION 8
26 kilograms/m^2
STANDARD_DEVIATION 5
25 kilograms/m^2
STANDARD_DEVIATION 4
Forced expiratory volume in one second (FEV1) (% of predicted)90 % of predicted value
STANDARD_DEVIATION 18
90 % of predicted value
STANDARD_DEVIATION 14
86 % of predicted value
STANDARD_DEVIATION 21
92 % of predicted value
STANDARD_DEVIATION 20
93 % of predicted value
STANDARD_DEVIATION 20
Height (cm)162 centimeters
STANDARD_DEVIATION 10
163 centimeters
STANDARD_DEVIATION 10
163 centimeters
STANDARD_DEVIATION 7
160 centimeters
STANDARD_DEVIATION 10
162 centimeters
STANDARD_DEVIATION 12
Sex: Female, Male
Female
28 Participants6 Participants7 Participants8 Participants7 Participants
Sex: Female, Male
Male
11 Participants3 Participants3 Participants2 Participants3 Participants
Side of surgery (R/L)
Left-sided surgery
15 Participants3 Participants3 Participants4 Participants5 Participants
Side of surgery (R/L)
Right-sided surgery
24 Participants6 Participants7 Participants6 Participants5 Participants
Time tu pleural opening (min)13 minutes
STANDARD_DEVIATION 5
12 minutes
STANDARD_DEVIATION 6
14 minutes
STANDARD_DEVIATION 6
12 minutes
STANDARD_DEVIATION 4
14 minutes
STANDARD_DEVIATION 4
Weight (kg)70 kilograms
STANDARD_DEVIATION 18
76 kilograms
STANDARD_DEVIATION 26
73 kilograms
STANDARD_DEVIATION 21
66 kilograms
STANDARD_DEVIATION 12
65 kilograms
STANDARD_DEVIATION 10

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 120 / 130 / 14
other
Total, other adverse events
0 / 100 / 120 / 130 / 14
serious
Total, serious adverse events
0 / 100 / 120 / 130 / 14

Outcome results

Primary

Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.

Time frame: From the beginning of OLV until 60 minutes

ArmMeasureValue (MEAN)Dispersion
Gas Movement Quantification With Double-lumen TubeQuantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.504 milliliters (mL)Standard Error 85
Gas Movement Quantification With Bronchial BlockerQuantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.630 milliliters (mL)Standard Error 86
Secondary

Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB

Intra-pulmonary pressure measured from initiation of OLV to pleural opening were similarly analyzed using a two-way ANOVA. Two experimental factors, one associated to the comparison between two groups (DLT versus BB), factor fixed and one associated to the comparison among results from the time periods (0 to 10 minutes), factor fixed with interaction terms between the fixed factors were defined. The data was analyzed using a repeated mixed model. An autoregressive covariance structure was used to consider the dependency among repeated measurements.

Time frame: From the beginning until 10 minutes of OLV

ArmMeasureGroupValue (MEAN)Dispersion
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB3 minutes-3.7 cmH2OStandard Error 0.6
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB6 minutes-8.8 cmH2OStandard Error 1.8
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB2 minutes-2.4 cmH2OStandard Error 0.4
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB7 minutes-10.7 cmH2OStandard Error 2.3
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB4 minutes-5.2 cmH2OStandard Error 0.9
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB8 minutes-13.6 cmH2OStandard Error 3.1
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB1 minutes-1.1 cmH2OStandard Error 0.3
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB9 minutes-16.3 cmH2OStandard Error 3.8
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB5 minutes-6.9 cmH2OStandard Error 1.3
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB10 minutes-20.6 cmH2OStandard Error 4.9
Gas Movement Quantification With Double-lumen TubeMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB0 minutes0 cmH2OStandard Error 0
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB10 minutes-28.3 cmH2OStandard Error 13.6
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB0 minutes0 cmH2OStandard Error 0
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB1 minutes-0.7 cmH2OStandard Error 1.2
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB2 minutes-2.6 cmH2OStandard Error 1.7
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB3 minutes-4.9 cmH2OStandard Error 2.6
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB4 minutes-8.9 cmH2OStandard Error 4.5
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB5 minutes-11.9 cmH2OStandard Error 5.6
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB6 minutes-14.2 cmH2OStandard Error 8
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB7 minutes-18.1 cmH2OStandard Error 9.4
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB8 minutes-19.7 cmH2OStandard Error 9.2
Gas Movement Quantification With Bronchial BlockerMeasurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB9 minutes-24.6 cmH2OStandard Error 12

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026