Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients (I-Nursing)

August 14, 2018 updated by: Chelly Jonathan, Hopital of Melun

Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study

Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.

The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation > 48 hours, inspired oxygen fraction < 60% and without neuromuscular blocking agent.

Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.

The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Melun, Ile De France, France, 77000
        • Centre Hospitalier de Melun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Invasive mechanical ventilation for expected time >48h

Exclusion Criteria:

  • Pregnancy
  • Neuromuscular blocking agent (discontinuous or continuous) infusion
  • Inspired oxygen fraction (FiO2) setting > or = 60%
  • Mobilization contraindication (hemodynamic instability, unstable vertebral trauma, etc.)
  • Neurological breathing (patients with brain injury)
  • Pulse oxymetry monitoring unavailable
  • Expected ventilation weaning <24h after randomization.
  • Moribund patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: INTELLIVENT-ASV / Conventional mode
Full closed-loop ventilation control (INTELLIVENT-ASV) is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to conventional ventilation 30 minutes before Nursing 2
Other: Nursing 1 : INTELLIVENT-ASV
Other: Nursing 2 : Conventional mode
Other: Conventional mode / INTELLIVENT-ASV
Conventional ventilation control is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to full closed-loop ventilation (INTELLIVENT-ASV) 30 minutes before Nursing 2.
Other: Nursing 2 : INTELLIVENT-ASV
Other: Nursing 1 : Conventional mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent with SpO2 values > 90 and < 95%
Time Frame: 1 day
Pulse oxymetry monitoring
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent with SpO2 values < or = 90%
Time Frame: 1 day
Pulse oxymetry monitoring
1 day
Time spent with SpO2 values > or = 95%
Time Frame: 1 day
Pulse oxymetry monitoring
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital of Melun

Investigators

  • Principal Investigator: Jonathan Chelly, MD, Mixed, ICU, Centre Hospitalier de Melun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MelunH-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Ill Patients

Clinical Trials on Nursing 1 : INTELLIVENT-ASV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe