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

NCT ID: NCT02919267

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Intra-pulmonary pressure determination

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.

Group Type: OTHER

Double lumen tube

Intervention Type: DEVICE

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

Bronchial blocker

Intervention Type: DEVICE

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

Volume determination

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.

Group Type: OTHER

Double lumen tube

Intervention Type: DEVICE

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

Bronchial blocker

Intervention Type: DEVICE

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

Interventions

Double lumen tube

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

Intervention Type: DEVICE

Bronchial blocker

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

Intervention Type: DEVICE

Other Intervention Names

Left-sided double lumen tube (BronchoCath, Mallinkrodt); Bronchial blocker (Fuji Uniblocker, Fuji Systems)

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Jean Bussières

Anesthesiologist, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Moreault, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Jean S Bussières, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , Canada

Countries

Canada

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Other Identifiers

IUCPQ 21299

Identifier Type: -

Identifier Source: org_study_id