Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

NCT02095496 | Completed DMC

• 1 other identifier: StLuc
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Mechanical Ventilatory Failure; Psychosis Associated With Intensive Care

Keywords

sleep; intensive care; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Sleep fragmentation index

  = number of awakenings and arousals per hour of sleep

  12 hours

Secondary Outcomes (2)

• duration of sleep episodes

  12 hours

• Distribution of the sleep

  12 hours

Other Outcomes (3)

• Sleep's architecture

  12 hours

• ventilation

  12 hours

• circadian rhythm

  6 hours

Study Arms (2)

Intellivent-ASV

EXPERIMENTAL

Patients will receive Intellivent-ASV ventilation during 12 hours

Device: Intellivent-ASV

Conventional ventilation

ACTIVE COMPARATOR

Patients will receive pressure support ventilation during 12 hours

Device: Conventional ventilation

Interventions

Intellivent-ASV DEVICE

12 hours of mechanical ventilation with intellivent-ASV

Also known as: closed-loop ventilation

Intellivent-ASV

Conventional ventilation DEVICE

12 hours of mechanical ventilation with pressure support ventilation

Also known as: pressure support ventilation

Conventional ventilation

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Intensive Care Unit, Saint Luc university Hospital

Brussels, 1200, Belgium

Location

Study Officials

• Emilie Bialais, PhD Student

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 24, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)