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

Primary Purpose

Acute Mechanical Ventilatory Failure, Psychosis Associated With Intensive Care

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Intellivent-ASV

Conventional ventilation

About this trial

This is an interventional diagnostic trial for Acute Mechanical Ventilatory Failure focused on measuring sleep, intensive care, mechanical ventilation

Eligibility Criteria

18 Years - 94 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Intensive Care Unit, Saint Luc university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intellivent-ASV

Conventional ventilation

Arm Description

Patients will receive Intellivent-ASV ventilation during 12 hours

Patients will receive pressure support ventilation during 12 hours

Outcomes

Primary Outcome Measures

Sleep fragmentation index

= number of awakenings and arousals per hour of sleep

Secondary Outcome Measures

duration of sleep episodes

Distribution of the sleep

distribution of the sleep during day and night

Full Information

NCT ID

NCT02095496

First Posted

March 4, 2014

Last Updated

January 29, 2016

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02095496

Brief Title

Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Acronym

SleepICU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Mechanical Ventilatory Failure, Psychosis Associated With Intensive Care

Keywords

sleep, intensive care, mechanical ventilation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intellivent-ASV

Arm Type

Experimental

Arm Description

Patients will receive Intellivent-ASV ventilation during 12 hours

Arm Title

Conventional ventilation

Arm Type

Active Comparator

Arm Description

Patients will receive pressure support ventilation during 12 hours

Intervention Type

Device

Intervention Name(s)

Intellivent-ASV

Other Intervention Name(s)

closed-loop ventilation

Intervention Description

12 hours of mechanical ventilation with intellivent-ASV

Intervention Type

Device

Intervention Name(s)

Conventional ventilation

Other Intervention Name(s)

pressure support ventilation

Intervention Description

12 hours of mechanical ventilation with pressure support ventilation

Primary Outcome Measure Information:

Title

Sleep fragmentation index

Description

= number of awakenings and arousals per hour of sleep

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

duration of sleep episodes

Time Frame

12 hours

Title

Distribution of the sleep

Description

distribution of the sleep during day and night

Time Frame

12 hours

Other Pre-specified Outcome Measures:

Title

Sleep's architecture

Description

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

Time Frame

12 hours

Title

ventilation

Description

number of asynchronies and apneas and ventilatory variability

Time Frame

12 hours

Title

circadian rhythm

Description

Plasmatic melatonin dosage

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

94 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emilie Bialais, PhD Student

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intensive Care Unit, Saint Luc university Hospital

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

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