Assessment of Post-operative Sore Throat After Scheduled General Anesthesia (POST)

March 25, 2020 updated by: University Hospital, Lille
Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient to be operated on in the Department of Surgical Specialties, Neurosurgery, Orthopaedics and Pediatric Surgery at the University Hospital of Lille

Description

Inclusion Criteria:

- General Anesthesia required Endotracheal or endobuccal device

Exclusion Criteria:

  • Tracheotomy per or post surgery
  • Patient with pre-operative pharyngeal irritation.
  • Patient with a prior respiratory tract infection.
  • Surgery of the laryngeal or tracheal vein, old or new
  • Surgery scheduled less than 24 hours ago.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of sore throat
Time Frame: Within 24 hours of surgery
Within 24 hours of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of sore throat,
Time Frame: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
type of sore throat risk factor
Time Frame: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
(technique of intubation, analgesic treatment for surgery…)
At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_96
  • 2019-A02077-50 (Other Identifier: ID-RCB number,ANSM)

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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