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

NCT ID: NCT03179644

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-08

Study Completion Date

2022-11-15

Brief Summary

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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

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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 These drains are gradually withdrawn during resuscitation usually after weaning mechanical ventilation

Conditions

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Respiratory Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bi-pulmonary transplantation

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.

Group Type EXPERIMENTAL

Measurement of oesophageal pressure and pleural pressure

Intervention Type OTHER

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

Interventions

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Measurement of oesophageal pressure and pleural pressure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Hôpital Nord Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2016-08

Identifier Type: -

Identifier Source: org_study_id

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