Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders (SleepICU)

Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients 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.

Study Overview

• Status: Completed
• Conditions: Acute Mechanical Ventilatory Failure; Psychosis Associated With Intensive Care
• Intervention / Treatment: Device: Intellivent-ASV; Device: Conventional ventilation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Intensive Care Unit, Saint Luc university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 94 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intellivent-ASV; Patients will receive Intellivent-ASV ventilation during 12 hours	Device: Intellivent-ASV; 12 hours of mechanical ventilation with intellivent-ASV; Other Names: closed-loop ventilation
Active Comparator: Conventional ventilation; Patients will receive pressure support ventilation during 12 hours	Device: Conventional ventilation; 12 hours of mechanical ventilation with pressure support ventilation; Other Names: pressure support ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep fragmentation index	= number of awakenings and arousals per hour of sleep	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of sleep episodes		12 hours
Distribution of the sleep	distribution of the sleep during day and night	12 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep's architecture	proportion of the different phases of sleep (slow waves sleep stage 1, 2, 3 and 4 and Rapid Eye Movement (REM) sleep)	12 hours
ventilation	number of asynchronies and apneas and ventilatory variability	12 hours
circadian rhythm	Plasmatic melatonin dosage	6 hours

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Emilie Bialais, PhD Student, Cliniques Universitaires Saint-luc

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; sleep; intensive care
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Sleep Wake Disorders; Parasomnias; Hypoventilation
• Other Study ID Numbers: StLuc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO