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OpenTrials
Completed

NCT Number: NCT02095496

Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.

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Key information

Age range

18 year–94 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit, Saint Luc university Hospital

Brussels, 1200, Belgium

About this study

In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day.
  • Age > 18 years
  • Body Mass Index < 40
  • informed consent signed by the family

Exclusion criteria

  • patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort
  • patient with encephalopathy regardless of origin
  • Patient with Glasgow coma scale score < 8
  • Patient abusing of drug or alcohol
  • patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx
  • Patient with bleeding disorders
  • Patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (PaO2/FiO2) < 100 mmHg with positive end expiratory pressure (PEEP) > 12 cmH2O
  • Patient with unstable hemodynamic situation as defined by Systolic Blood Pressure (SBP) < 75 mmHg despite a therapeutic optimization
  • Inclusion in another research protocol submitted to consent

Treatment and study plan

Intellivent-ASV

Device

12 hours of mechanical ventilation with intellivent-ASV

Other names: closed-loop ventilation

Conventional Ventilation

Device

12 hours of mechanical ventilation with pressure support ventilation

Other names: pressure support ventilation

Primary outcomes

  1. Sleep fragmentation index

    Time frame: 12 hours

    = number of awakenings and arousals per hour of sleep

Secondary outcomes

  1. duration of sleep episodes

    Time frame: 12 hours

  2. Distribution of the sleep

    Time frame: 12 hours

    distribution of the sleep during day and night

Other outcomes

  1. Sleep's architecture

    Time frame: 12 hours

    proportion of the different phases of sleep (slow waves sleep stage 1, 2, 3 and 4 and Rapid Eye Movement (REM) sleep)

  2. ventilation

    Time frame: 12 hours

    number of asynchronies and apneas and ventilatory variability

  3. circadian rhythm

    Time frame: 6 hours

    Plasmatic melatonin dosage

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders

Acronym: SleepICU

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2014
Registry last updated
Feb 1, 2016

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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