NCT01047852

Brief Summary

The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

6 active sites

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

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

January 5, 2010

Last Update Submit

March 4, 2015

Conditions

Respiratory Failure

Keywords

chronic respiratory disordershypercapnic respiratory failurenoninvasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Incidence of respiratory failure after extubation

    2 days

Secondary Outcomes (6)

  • Incidence of reintubation

    2 months

  • Length of stay in Intensive Care Unit

    2 months

  • Hospital mortality

    2 months

  • Survival

    28th day

  • Survival

    90th day

  • +1 more secondary outcomes

Study Arms (2)

NIV

EXPERIMENTAL
Procedure: Noninvasive ventilation

Control

NO INTERVENTION

Interventions

Noninvasive ventilationPROCEDURE

NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula

NIV

Eligibility Criteria

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

You may qualify if:

  • Patients intubated for 48 hours or more
  • Patients with Chronic respiratory disorders
  • And/or hypercapnic respiratory failure during successful spontaneous breathing trial

You may not qualify if:

  • Face or cranial trauma or surgery
  • Home noninvasive ventilation
  • Recent gastric or oesophageal surgery
  • Tracheostomy or other upper airway disorders
  • Upper gastrointestinal bleeding
  • Excess respiratory secretions
  • Lack of collaboration
  • Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital

Agen, 47923, France

Location

Saint-André Hospital

Bordeaux, 33075, France

Location

Pellegrin Hospital, Recovery Unit

Bordeaux, 33076, France

Location

Hospital

Libourne, 33505, France

Location

University Hospital

Limoges, 87042, France

Location

University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

  • Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.

    PMID: 28393258DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Frédéric VARGAS, MD

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Olivier GUISSET, MD

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Marc CLAVEL, MD

    University Hospital, Limoges, France

    PRINCIPAL INVESTIGATOR

  • Pascale SANCHEZ, MD

    University Hospital, Toulouse, France

    PRINCIPAL INVESTIGATOR

  • Sylvain GARNIER, MD

    Hospital, Libourne, France

    PRINCIPAL INVESTIGATOR

  • Aissa KHERCHACHE, MD

    Hospital, Agen, France

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, MD

    University Hospital, Bordeaux, France

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 13, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

FR(6)