Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? (KISEVEN)

October 3, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial

Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
  • Major Patient over 18 years of age
  • Patient affiliated to social security

Exclusion Criteria:

  • Sedate
  • With restrictive or tracheotomized syndrome
  • With rib fractures
  • Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol
  • Refusal of patient or family
  • Physiotherapy contraindications
  • Patient under tutorship or curatorship
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient receiving respiratory physiotherapy
Other: Study on patients with respiratory resuscitation
Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
OTHER: Patient not receiving respiratory physiotherapy
Other: Study on patients with respiratory resuscitation
Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time between initiation of weaning protocol and extubation.
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2016

Primary Completion (ACTUAL)

April 27, 2017

Study Completion (ACTUAL)

April 27, 2017

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (ACTUAL)

April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PI2015_843_0014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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