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Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms (PLC-OLV)

Primary Purpose

Lung Collapse, One-Lung Ventilation, Thoracic Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Double lumen tube
Bronchial blocker
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Collapse focused on measuring One lung ventilation, Lung collapse, Bronchial blocker, Double lumen tube, video assisted thoracoscopic surgery, VATS, DLT, Thoracic surgery, Video-assisted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 exclusion criteria :

  • severe desaturation before or during the observation period
  • any clinical situation precluding the use of one of the lung isolation device
  • air leak at the level of bronchial isolation

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intra-pulmonary pressure determination

Volume determination

Arm Description

A pressure tubing catheter will be connected to the luerlock adaptor of the bronchial blocker (BB) or to the adaptor located on the side of the occluding system mounted at the extremity of the double lumen tube (DLT). The catheter will then be connected to a differential pressure transducer (AD Instruments, Colorado Springs, CO, USA), allowing direct visualisation of the bronchial pressures. Along with intra-bronchial pressure, esophageal pressure will also be measured to eliminate the pressure generated by the positive pressure of the ventilated lung (Adult esophageal balloon catheter, Cooper Surgical, Trumbull, CT, USA). Intra-bronchial pressures will be measured at end-inspiration and end-expiration.

A one-liter bag (Roxon, Etobicoke, ON, Canada) will be filled precisely with 300 mL of air with the use of a calibrated syringe of 3 liters (Hans Rudolph inc, Shawnee, Kansas, United States), through a three-way valve (Hans Rudolph inc, Shawnee, Kansas, United States). Following the filling of the bag, it will be connected to the non-ventilated lumen of the double lumen tube (DLT) or to the bronchial blocker (BB) through the three-way connector. At the end of the observation period, the collector bag will be connected to the calibrated syringe and will emptied from its residual volume.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2016
Last Updated
May 11, 2020
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02919267
Brief Title
Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
Acronym
PLC-OLV
Official Title
Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-pulmonary pressure determination
Arm Type
Other
Arm Description
A pressure tubing catheter will be connected to the luerlock adaptor of the bronchial blocker (BB) or to the adaptor located on the side of the occluding system mounted at the extremity of the double lumen tube (DLT). The catheter will then be connected to a differential pressure transducer (AD Instruments, Colorado Springs, CO, USA), allowing direct visualisation of the bronchial pressures. Along with intra-bronchial pressure, esophageal pressure will also be measured to eliminate the pressure generated by the positive pressure of the ventilated lung (Adult esophageal balloon catheter, Cooper Surgical, Trumbull, CT, USA). Intra-bronchial pressures will be measured at end-inspiration and end-expiration.
Arm Title
Volume determination
Arm Type
Other
Arm Description
A one-liter bag (Roxon, Etobicoke, ON, Canada) will be filled precisely with 300 mL of air with the use of a calibrated syringe of 3 liters (Hans Rudolph inc, Shawnee, Kansas, United States), through a three-way valve (Hans Rudolph inc, Shawnee, Kansas, United States). Following the filling of the bag, it will be connected to the non-ventilated lumen of the double lumen tube (DLT) or to the bronchial blocker (BB) through the three-way connector. At the end of the observation period, the collector bag will be connected to the calibrated syringe and will emptied from its residual volume.
Intervention Type
Device
Intervention Name(s)
Double lumen tube
Other Intervention Name(s)
Left-sided double lumen tube (BronchoCath, Mallinkrodt)
Intervention Description
Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group.
Intervention Type
Device
Intervention Name(s)
Bronchial blocker
Other Intervention Name(s)
Bronchial blocker (Fuji Uniblocker, Fuji Systems)
Intervention Description
Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 exclusion criteria : severe desaturation before or during the observation period any clinical situation precluding the use of one of the lung isolation device air leak at the level of bronchial isolation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Moreault, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean S Bussières, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
Country
Canada

12. IPD Sharing Statement

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

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