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CompletedNCT04409652Updated Nov 9, 2023

Head Position on Preventing Emergence Cough

An interventional study of Head on bed and Head on pillow in Gallbladder Diseases, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gallbladder Diseases

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03

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • BMI > 30 kg/m2
  • Respiratory infection
  • Uncontrolled hypertension
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
72 participants (actual)

Study arms

  • Placebo comparator
    Control group

    The endotracheal extubation is performed in head on bed without pillow.

    Procedure: Head on bed

  • 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

Interventions

  • ProcedureHead on bed

    During emergence, head is kept on bed without pillow.

  • ProcedureHead on pillow

    During emergence, head is kept on pillow.

05

What researchers measure

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

    Time frame: during extubation

06

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
    Suwon, Korea, Republic of
07

Registry details

Key details

Study ID
NCT04409652
Lead sponsor
Ajou University School of Medicine
Responsible party
Ji Eun Kim (Associate professor, Ajou University School of Medicine) — Principal investigator
First posted
Jun 1, 2020
Start date
Jun 2, 2020
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Nov 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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