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

NCT04159220 | Completed

• 1 other identifier: RECHMPL19_0070
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• Measure of the pa02/Fi02

  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.

  1 hour after the end of the transport

Secondary Outcomes (6)

• Assessment of the pa02

  1 hour after the end of the HIT

• Assessment of the pa02

  immediately after the end of the HIT

• Assessment of the pa02

  6 hours after the end of of the HIT

• length of stay

  up to 28 days

• duration of invasive ventilation

  up to 28 days

Study Arms (2)

Control group

NO INTERVENTION

The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator.

Clamping group

EXPERIMENTAL

The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator.

Procedure: Clamping of the ventilator endotracheal tube

Interventions

Clamping of the ventilator endotracheal tube PROCEDURE

The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.

Clamping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient Covid tests positive or Covid test results not received
• extubated, unsedated,
• reinforced tube
• tracheotomy
• pregnancy
• guardianship

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)

Montpellier, 34295, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: January 17, 2020
• Primary Completion: December 18, 2023
• Study Completion: December 22, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (1)