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Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of oesophageal pressure and pleural pressure
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent.

Exclusion Criteria:

  • Age less than 18 years, Pregnancy, breast feeding, adults under guardianship or under safeguard justice, not beneficiaries of a social security scheme, persons deprived of liberty by a judicial or administrative decision , those hospitalized without consent Single lung transplant
  • Open chest at the end of transplantation
  • high flow pleura-pulmonary fistula (Contraindication to the establishment of a nasogastric tube proven presence of esophageal varices esophageal tumor Surgery of the esophagus of less than 1 year

Sites / Locations

  • Hôpital Nord Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bi-pulmonary transplantation

Arm Description

Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent.

Outcomes

Primary Outcome Measures

Oesophageal pressure
The oesophageal pressure will be measured with a nasogastric tube with an esophageal balloon (also enabling the patient to be fed)(6 measurements at the end of inspiration and 6 at the end of expiration).
Pleural pressure
The pleural pressure will be measured using several pleurocath-type catheters (Prodimed Inc, France)(4 inspiratory measures and 4 expiratory measures)

Secondary Outcome Measures

Correlations between the mean pleural pressure and esophageal pressure during the 5 days following a double lung transplant.
Comparison between the pleural pressure and esophageal pressure depending on the lung injury, the ventilation mode and the body position (supine and prone position)

Full Information

First Posted
May 31, 2017
Last Updated
November 15, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03179644
Brief Title
Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation
Official Title
Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2016 (Actual)
Primary Completion Date
April 16, 2017 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study is to determine the correlation between mean pleural pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation. In this research, oesophageal pressure will be measured by a nasogastric tube with an esophageal balloon (also suitable for feeding the patient) usually installed at the time of transplantation, pleural pressure will be measured by several Pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the surgery without additional skin intrusion.
Detailed Description
Pulmonary transplantation is a model of acute lung injury due to ischemia-reperfusion phenomena responsible in 1 in 4 patients for the occurrence of primary graft dysfunction (DPG), which penalizes graft prognosis in the short to medium term. The survival of transplant patients. Furthermore, the post-operative period is a complex period in which multiple hemorrhagic, immunological, infectious, and neuromuscular complications may arise that may require prolonged mechanical ventilation. At present, there are no data on the measurement of pressure in pleural space after pulmonary transplantation. Achieving this measurement would make it possible to adapt the settings of the ventilator to both the acute phase in the case of DPG and to a later phase in case of mechanical weaning. In the case of bi-pulmonary transplantation, before the thorax is closed, each patient benefits from the systematic placement of bilateral anterior and posterior thoracic drains to prevent the formation of fluid effusions (hemothorax, pleurisy) and / or gases (pneumothorax ) Which would impede ventilation and compromise gas exchange. These drains are gradually withdrawn during resuscitation usually after weaning mechanical ventilation

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant, the objective is to To assess the correlation between the mean pleural pressure and esophageal pressure
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bi-pulmonary transplantation
Arm Type
Experimental
Arm Description
Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent.
Intervention Type
Other
Intervention Name(s)
Measurement of oesophageal pressure and pleural pressure
Intervention Description
Measurement of oesophageal pressure by a nasogastric tube with an esophageal balloon (also enabling the patient to be fed) and pleural pressure measurement by means of several pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have previously Positioned at the end of the surgery without any additional skin intrusion
Primary Outcome Measure Information:
Title
Oesophageal pressure
Description
The oesophageal pressure will be measured with a nasogastric tube with an esophageal balloon (also enabling the patient to be fed)(6 measurements at the end of inspiration and 6 at the end of expiration).
Time Frame
5 days
Title
Pleural pressure
Description
The pleural pressure will be measured using several pleurocath-type catheters (Prodimed Inc, France)(4 inspiratory measures and 4 expiratory measures)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Correlations between the mean pleural pressure and esophageal pressure during the 5 days following a double lung transplant.
Time Frame
5 days
Title
Comparison between the pleural pressure and esophageal pressure depending on the lung injury, the ventilation mode and the body position (supine and prone position)
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent. Exclusion Criteria: Age less than 18 years, Pregnancy, breast feeding, adults under guardianship or under safeguard justice, not beneficiaries of a social security scheme, persons deprived of liberty by a judicial or administrative decision , those hospitalized without consent Single lung transplant Open chest at the end of transplantation high flow pleura-pulmonary fistula (Contraindication to the establishment of a nasogastric tube proven presence of esophageal varices esophageal tumor Surgery of the esophagus of less than 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Nord Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

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