Head Position on Preventing Emergence Cough | NCT04409652

Studies
Head Position on Preventing Emergence Cough

NCT04409652

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Nov 9, 2023Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Gallbladder Diseases

Interventions

Head on bed
Head on pillow

Countries

South Korea

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

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

May 25, 2020

First Submission Date that Met QC Criteria

May 27, 2020

First Posted Date

Jun 1, 2020Actual

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

Nov 7, 2023

Last Update Posted Date

Nov 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Eun Kim, Associate professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.

Detailed Description

During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Placebo Comparator	The endotracheal extubation is performed in head on bed without pillow.	Procedure: Head on bed
Head elevation group	Active Comparator	The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .	Procedure: Head on pillow

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head on bed	Procedure	During emergence, head is kept on bed without pillow.	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The severity of cough	0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough	during extubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Operation schedule of laparoscopic cholecystectomy
Must be performed under general anesthesia

Exclusion Criteria:

BMI > 30 kg/m2
Respiratory infection
Uncontrolled hypertension

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine		Suwon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided