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

Respiratory Complication Clinical Trial

— ESCORTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159220
• Other study ID #: RECHMPL19_0070
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 22, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Patient Covid tests positive or Covid test results not received

• extubated, unsedated,

• reinforced tube

• tracheotomy

• pregnancy

• guardianship

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

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.

Locations

Country	Name	City	State
France	Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of the pa02	Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)	1 hour after the end of the HIT
Secondary	Assessment of the pa02	Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator	immediately after the end of the HIT
Secondary	Assessment of the pa02	Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator	6 hours after the end of of the HIT
Secondary	length of stay	Evaluate the impact of the intervention on the length of ICU stay	up to 28 days
Secondary	duration of invasive ventilation	Evaluate the impact of the intervention on the invasive ventilation	up to 28 days
Secondary	occurrence of adverse events during the HIT	occurrence of adverse events related to the clamping	immediately after the end of the HIT