NCT03972423

Brief Summary

This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

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

February 18, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

November 12, 2020

Status Verified

May 1, 2019

Enrollment Period

Same day

First QC Date

May 26, 2019

Last Update Submit

November 9, 2020

Conditions

Keywords

checklistpostoperative complicationanesthesiainformation transmissioncare unit

Outcome Measures

Primary Outcomes (1)

  • arterial oxygen desaturation < 90%

    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

Study Arms (2)

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.

Other: With or wiyhout a checklist

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.

Other: With or wiyhout a checklist

Interventions

The evaluation of the impact of the use of this Checklist will be done in comparison with the standard transmission practice

CONTROL groupIRCTC group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients admitted to PACU

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Franciscaines Clinic

Versailles, IDF, 78000, France

Location

Related Publications (1)

  • Jaulin F, Lopes T, Martin F. Standardised handover process with checklist improves quality and safety of care in the postanaesthesia care unit: the Postanaesthesia Team Handover trial. Br J Anaesth. 2021 Dec;127(6):962-970. doi: 10.1016/j.bja.2021.07.002. Epub 2021 Aug 5.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic Martin

    Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2019

First Posted

June 3, 2019

Study Start

February 18, 2019

Primary Completion

February 18, 2019

Study Completion

July 7, 2020

Last Updated

November 12, 2020

Record last verified: 2019-05

Locations