ClinicalTrials.gg
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

In context

Gallbladder Diseases

92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.

This study's enrollment of 72 is close to the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.

Browse Gallbladder Diseases studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • > 30 kg/m2
  • Respiratory infection
  • Uncontrolled hypertension
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

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.

06

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

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
    Suwon, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Dec 2022, 30 months.

Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 30 months is above that.

Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2020
First posted
Jun 1, 2020
StartActual
Jun 2, 2020
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Nov 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04409652
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 ↗

Not currently enrolling

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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