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Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care (ESCORTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159220
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.

Condition or disease Intervention/treatment Phase
Respiratory Complication Procedure: Clamping of the ventilator endotracheal tube Not Applicable

Detailed Description:

Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.

Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.

This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
No Intervention: Control group
The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator.
Experimental: Clamping group
The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator.
Procedure: Clamping of the ventilator endotracheal tube
The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.




Primary Outcome Measures :
  1. Measure of the pa02/Fi02 [ Time Frame: 1 hour after the end of the transport ]
    Evaluate the effectiveness of a procedure to avoid alveolar delisting, measured by the absence of a decrease in the PaO2/FiO2 ratio (before transport and 1 hour after return to bed) during an HIT performed by a nurse anaesthetist/caregiver team, of intubated and ventilated resuscitation patients in a controlled assisted volume.


Secondary Outcome Measures :
  1. Assessment of the pa02 [ Time Frame: 1 hour after the end of the HIT ]
    Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)

  2. Assessment of the pa02 [ Time Frame: immediately after the end of the HIT ]
    Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator

  3. Assessment of the pa02 [ Time Frame: 6 hours after the end of of the HIT ]
    Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator

  4. length of stay [ Time Frame: up to 28 days ]
    Evaluate the impact of the intervention on the length of ICU stay

  5. duration of invasive ventilation [ Time Frame: up to 28 days ]
    Evaluate the impact of the intervention on the invasive ventilation

  6. occurrence of adverse events during the HIT [ Time Frame: immediately after the end of the HIT ]
    occurrence of adverse events related to the clamping



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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:

  • intensive care patient
  • intubated, sedated, controlled assisted ventilation
  • Intra hospital transport for CT scan
  • arterial catheter
  • the patient or his trusted person consent to the study

Exclusion Criteria:

  • extubated, unsedated,
  • reinforced tube
  • tracheotomy
  • pregnancy
  • guardianship

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): NCT04159220


Contacts
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Contact: Christine BERNARD, nurse 0033467337476 christine.bernard@chu-montpellier.fr

Locations
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France
Departement d'anesthésie et réanimation Gui de Chauliac (DAR C) Recruiting
Montpellier, France, 34295
Contact: christine Bernard, nurse    0033467337476    christine.bernard@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04159220    
Other Study ID Numbers: RECHMPL19_0070
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 12 months after the main publication
Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

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