NCT03114787

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 30, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

April 5, 2017

Last Update Submit

October 3, 2018

Conditions

Respiratory PhysiotherapyResuscitation

Outcome Measures

Primary Outcomes (1)

  • Time between initiation of weaning protocol and extubation.

    8 months

Study Arms (2)

Patient receiving respiratory physiotherapy

OTHER
Other: Study on patients with respiratory resuscitation

Patient not receiving respiratory physiotherapy

OTHER
Other: Study on patients with respiratory resuscitation

Interventions

Study on patients with respiratory resuscitationOTHER

Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult

Patient not receiving respiratory physiotherapyPatient receiving respiratory physiotherapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

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

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 14, 2017

Study Start

August 30, 2016

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations

FR(1)