Head Position on Preventing Emergence Cough

November 7, 2023 updated by: Ji Eun Kim, Ajou University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

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

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
The endotracheal extubation is performed in head on bed without pillow.
Procedure: Head on bed
During emergence, head is kept on bed without pillow.
Active Comparator: Head elevation group
The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .
Procedure: Head on pillow
During emergence, head is kept on pillow.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

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 (Actual)

June 2, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-OBS-20-055

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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