Sleep Quality and Risk of Intubation in Intensive Care Un... | NCT02907008

Studies
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

NCT02907008

Sponsor

Poitiers University Hospital

Status

Unknown status

Last Update Posted

Feb 22, 2019Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Sleep Quality
Hypoxemic Acute Respiratory Failure
Intubation Risk

Interventions

Polysomnography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

May 2020Estimated

First Submitted Date

Sep 15, 2016

First Submission Date that Met QC Criteria

Sep 15, 2016

First Posted Date

Sep 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2019

Last Update Posted Date

Feb 22, 2019Actual

Description Module

Brief Summary

The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep		24h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute respiratory failure
hypoxemia with PaO2/FiO2 ratio < 300 mmHg
aged of 18 years or more

Exclusion Criteria:

Need of immediate intubation
Need of vasopressor drugs
coma with Glasgow scale < 8
Acute respiratory failure linked to cardiogenic pulmonary oedema
Chronic respiratory insufficiency
Peripheral or central nervous system pathology
Known psychiatric pathology or agitation
Patient with decision of no intubation
Patient refusal
Pregnant or breastfeeding women
Patient under legal guardianship or protection
Patients with no health insurance coverage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

intensive care units patients with hypoxemic acute respiratory failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arnaud W THILLE, PHD	Contact			arnaud.thille@chu-poitiers.fr
Damien MARIE, Intern	Contact			damien.marie01@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Poitiers	Recruiting	Poitiers		86000	France

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided