NCT04409652

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

May 25, 2020

Last Update Submit

November 7, 2023

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Head on bedPROCEDURE

During emergence, head is kept on bed without pillow.

Control group
Head on pillowPROCEDURE

During emergence, head is kept on pillow.

Head elevation group

Eligibility Criteria

Age19 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Operation schedule of laparoscopic cholecystectomy
  • Must be performed under general anesthesia

You may not qualify if:

  • BMI \> 30 kg/m2
  • Respiratory infection
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, South Korea

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 1, 2020

Study Start

June 2, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

KR(1)