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Trial record 47 of 227 for:    Recruiting, Not yet recruiting, Available Studies | "informed consent"

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

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ClinicalTrials.gov Identifier: NCT03179644
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Respiratory Disease Other: Measurement of oesophageal pressure and pleural pressure Not Applicable

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 These drains are gradually withdrawn during resuscitation usually after weaning mechanical ventilation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation
Actual Study Start Date : July 8, 2016
Estimated Primary Completion Date : July 8, 2018
Estimated Study Completion Date : July 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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




Primary Outcome Measures :
  1. Oesophageal pressure [ Time Frame: 5 days ]
    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).

  2. Pleural pressure [ Time Frame: 5 days ]
    The pleural pressure will be measured using several pleurocath-type catheters (Prodimed Inc, France)(4 inspiratory measures and 4 expiratory measures)


Secondary Outcome Measures :
  1. Correlations between the mean pleural pressure and esophageal pressure during the 5 days following a double lung transplant. [ Time Frame: 5 days ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179644


Contacts
Contact: Christophe GUERVILLY 0491965835 christophe.guervilly@ap-hm.fr

Locations
France
Hôpital Nord Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Christophe GUERVILLY    0491965835    christophe.guervilly@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean-Olivier ARNAUD Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03179644     History of Changes
Other Study ID Numbers: 2016-08
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases