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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176329
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Chelly Jonathan, Hopital of Melun

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Critical Ill Patients Ventilated Patients Other: Nursing 1 : INTELLIVENT-ASV Other: Nursing 2 : INTELLIVENT-ASV Other: Nursing 1 : Conventional mode Other: Nursing 2 : Conventional mode Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective randomized crossover study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. Time spent with SpO2 values > 90 and < 95% [ Time Frame: 1 day ]
    Pulse oxymetry monitoring


Secondary Outcome Measures :
  1. Time spent with SpO2 values < or = 90% [ Time Frame: 1 day ]
    Pulse oxymetry monitoring

  2. Time spent with SpO2 values > or = 95% [ Time Frame: 1 day ]
    Pulse oxymetry monitoring



Information from the National Library of Medicine

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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:

  • 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

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): NCT03176329


Locations
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France
Centre Hospitalier de Melun
Melun, Ile De France, France, 77000
Sponsors and Collaborators
Hopital of Melun
Investigators
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Principal Investigator: Jonathan Chelly, MD Mixed, ICU, Centre Hospitalier de Melun
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chelly Jonathan, MD, Hopital of Melun
ClinicalTrials.gov Identifier: NCT03176329    
Other Study ID Numbers: MelunH-02
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chelly Jonathan, Hopital of Melun:
Full closed-loop ventilation control
Critical care