Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Acute Mechanical Ventilatory Failure Clinical Trial

— SleepICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095496
• Other study ID #: StLuc
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: January 29, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 94 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Mechanical Ventilatory Failure
• Hypoventilation
• Parasomnias
• Psychosis Associated With Intensive Care
• Sleep Disorders

Intervention

Device:
• Intellivent-ASV
12 hours of mechanical ventilation with intellivent-ASV
• Conventional ventilation
12 hours of mechanical ventilation with pressure support ventilation

Locations

Country	Name	City	State
Belgium	Intensive Care Unit, Saint Luc university Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	ventilation	number of asynchronies and apneas and ventilatory variability	12 hours	No
Other	circadian rhythm	Plasmatic melatonin dosage	6 hours	No
Primary	Sleep fragmentation index	= number of awakenings and arousals per hour of sleep	12 hours	No
Secondary	duration of sleep episodes		12 hours	No
Secondary	Distribution of the sleep	distribution of the sleep during day and night	12 hours	No