NCT01931228

Brief Summary

Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality. the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

August 22, 2013

Last Update Submit

January 19, 2018

Conditions

Acute Respiratory InsufficiencyRespiratory Failure

Keywords

Intensive care unitacute respiratory insufficiencyRespiratory failureMechanical Insufflation-Exsufflation

Outcome Measures

Primary Outcomes (1)

  • Incidence of respiratory failure after extubation

    48h post extubation (48h after inclusion)

Secondary Outcomes (7)

  • the increase in peak cough flow

    End of intensive care or day 28 after inclusion

  • the incidence of reintubation

    End of intensive care or day 28 after inclusion

  • the average time of hospitalization in the intensive care unit

    End of intensive care or day 28 after inclusion

  • the incidence of nasotracheal suction

    End of intensive care or day 28 after inclusion

  • the number of additional physiotherapy sessions

    End of intensive care or day 28 after inclusion

  • +2 more secondary outcomes

Study Arms (2)

MI-E plus manually assisted coughing

EXPERIMENTAL
Procedure: MI-E plus manually assisted coughing

Manually assisted coughing only

EXPERIMENTAL
Procedure: manually assisted coughing

Interventions

MI-E plus manually assisted coughingPROCEDURE

MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.

MI-E plus manually assisted coughing
manually assisted coughingPROCEDURE

Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.

Manually assisted coughing only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient aged ≥ 18 years.
  • Patient admitted in participant ICU.
  • Patient intubated for 48 hours at least.
  • Patient presenting an ICU acquired neuromuscular disorders.

You may not qualify if:

  • Respiratory or haemodynamic instability.
  • Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.
  • Severe ventricular rhythm disorders.
  • Patient with tracheotomy.
  • Uncontrollable vomiting.
  • Severe sepsis.
  • Upper airway disorders.
  • Upper gastrointestinal bleeding.
  • Any decision to limit therapeutic effort in the ICU.
  • Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

  • Wibart P, Reginault T, Garcia-Fontan M, Barbrel B, Bader C, Benard A, Parreira VF, Gonzalez-Anton D, Bui NH, Gruson D, Hilbert G, Martinez-Alejos R, Vargas F. Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial. Crit Care Sci. 2023 Apr-Jun;35(2):168-176. doi: 10.5935/2965-2774.20230410-en.

    PMID: 37712806DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Philippe WIBART, Physical therapist

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, MD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 29, 2013

Study Start

May 3, 2012

Primary Completion

February 1, 2015

Study Completion

May 1, 2016

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

FR(1)