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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176329
Acronym
I-Nursing
Enrollment
267
Registered
2017-06-05
Start date
2016-09-19
Completion date
2018-07-31
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Ill Patients, Ventilated Patients

Keywords

Full closed-loop ventilation control, Critical care

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.

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.

Interventions

OTHERNursing 1 : INTELLIVENT-ASV
OTHERNursing 2 : INTELLIVENT-ASV
OTHERNursing 1 : Conventional mode
OTHERNursing 2 : Conventional mode

Sponsors

Hopital of Melun
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Prospective randomized crossover study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time spent with SpO2 values > 90 and < 95%1 dayPulse oxymetry monitoring

Secondary

MeasureTime frameDescription
Time spent with SpO2 values < or = 90%1 dayPulse oxymetry monitoring
Time spent with SpO2 values > or = 95%1 dayPulse oxymetry monitoring

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026