Maximal Inspiratory Pressure at Extubation: Relationship... | NCT02363231

Studies
Maximal Inspiratory Pressure at Extubation: Relationship With Mortality

NCT02363231

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Jan 12, 2016Estimated

Enrollment

124Actual

Phase

Not provided

Conditions

Mechanical Ventilation

Interventions

Not provided

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 13, 2015Estimated

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

Jan 8, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The process of weaning from mechanical ventilation was decided after clinical judgment and weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of respiratory muscles in critically ill patients has not been established. The objective of this study was to assess the relationship on MIP at extubation on one-year mortality in critically ill patients.

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

124Actual

Label	Type	Description	Intervention Names
patients under mechanical ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		One year after extubation

Secondary Outcomes

Measure	Description	Time Frame
Time to mechanical ventilation weaning		During Intensive care unit hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mechanical ventilation at least at 24 hours

Exclusion Criteria:

Delirium
Cognitive dysfunction
refusal to participate

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

Critically ill patient under invasive mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clement Medrinal	Groupe Hospitalier du Havre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Le Havre, Jacques Monod Hospital		Montivilliers		76290	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33438092	Derived	Combret Y, Prieur G, Hilfiker R, Gravier FE, Smondack P, Contal O, Lamia B, Bonnevie T, Medrinal C. The relationship between maximal expiratory pressure values and critical outcomes in mechanically ventilated patients: a post hoc analysis of an observational study. Ann Intensive Care. 2021 Jan 13;11(1):8. doi: 10.1186/s13613-020-00791-4.
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