- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03972423
Impact of a Transmission Checklist in Post Anesthesia Care Unit on Immediate Respiratory Complications (TC-IRC)
Study Overview
Status
Intervention / Treatment
Detailed Description
Communication and information transmission problems are responsible for the majority of serious adverse events. The use of a checklist in the operating theatre has demonstrated its benefit in terms of reducing morbidity and mortality Regarding transmissions between caregivers, numerous studies have shown the great difference between the medical data of a patient in their file and the information transmitted.
The authors recommend using checklists in order to standardise transmissions. This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted. On the other hand, no study has looked at the reduction of immediate postoperative complications in post anaesthesia care units (PACU).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
IDF
-
Versailles, IDF, France, 78000
- Les Franciscaines Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or Female over 18 admitted to PACU
Patient having understood the aims and the methods of the research
- Patient having expressed their consent to the use of their data.
- Subject registered with or beneficiary of a social security scheme
Exclusion Criteria:
- Patient participating in another clinical study
- Acute or chronic respiratory insufficiency preoperatively
- Protected patient: adult under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
IRCTC group
- The IRCTC group, consisting of all patients included in the 3rd phase of the study and for whom the transmission of information in PACU is carried out using the IRCTC.
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The evaluation of the impact of the use of this Checklist will be done in comparison with the standard transmission practice
|
|
CONTROL group
- The CONTROL group, consisting of all patients included in the 1st phase of the study and for whom the transmission of information in PACU is carried out according to the usual practice.
|
The evaluation of the impact of the use of this Checklist will be done in comparison with the standard transmission practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
arterial oxygen desaturation < 90%
Time Frame: event of at least 15 second duration
|
The primary endpoint is defined as the occurrence or not of arterial oxygen desaturation < 90% for more than 15 consecutive seconds in PACU.
|
event of at least 15 second duration
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frederic Martin, Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-RCB : 2018-A01825-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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