Assessment of Post-operative Sore Throat After Scheduled... | NCT04115865

Studies
Assessment of Post-operative Sore Throat After Scheduled General Anesthesia

NCT04115865

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

Mar 27, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Sore Throat
Intubation;Difficult

Interventions

Endotracheal sonde or laryngeal mask

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02077-50	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

refusal ethics comity

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 2, 2019

First Posted Date

Oct 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2020

Last Update Posted Date

Mar 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotracheal sonde or laryngeal mask	Device	Healthy subjects ; requiring general anesthesia with endotracheal or endobuccal device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of sore throat		Within 24 hours of surgery

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elsa Jozefowicz, MD	University Hospital, Lille	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017214	Laryngeal Masks

Ancestor Terms

ID	Term
D007442	Intubation, Intratracheal
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation

Browse Leaves

Not provided

Browse Branches

Not provided