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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114787
Recruitment Status : Terminated (The patient recruiting was stopped after 17 inclusions because of a reorganization of Intensive Care Units at the recruiting center.)
First Posted : April 14, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment Phase
Respiratory Physiotherapy Resuscitation Other: Study on patients with respiratory resuscitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : April 27, 2017
Actual Study Completion Date : April 27, 2017

Arm Intervention/treatment
Patient receiving respiratory physiotherapy Other: Study on patients with respiratory resuscitation
Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult

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




Primary Outcome Measures :
  1. Time between initiation of weaning protocol and extubation. [ Time Frame: 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114787


Locations
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France
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03114787    
Other Study ID Numbers: PI2015_843_0014
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No