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Completed

NCT Number: NCT03176329

Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients

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.

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Key information

Conditions

Critical Ill Patients Ventilated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Melun

Melun, Île-de-France Region, 77000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nursing 1 : INTELLIVENT-ASV

Other

Nursing 2 : INTELLIVENT-ASV

Other

Nursing 1 : Conventional mode

Other

Nursing 2 : Conventional mode

Other

Primary outcomes

  1. Time spent with SpO2 values > 90 and < 95%

    Time frame: 1 day

    Pulse oxymetry monitoring

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital of Melun

Other

Registry information

Official study title

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

Acronym: I-Nursing

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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