NCT03770715

Brief Summary

Sleep apnea is common after extubation, approximately 71%, and is independently associated with hypertension and metabolic disease contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea. The aim of this study is to evaluate the prevalence of sleep apnea after extubation by respiratory polygraphy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

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

Study Start

First participant enrolled

August 17, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

December 7, 2018

Last Update Submit

December 2, 2019

Conditions

Keywords

Sleep ApneaRespiratory polygraphyExtubation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sleep apnea after exutbation

    during first to second night following extubation

Interventions

The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral hospital

You may qualify if:

  • patients after extubation

You may not qualify if:

  • pregnant
  • non-consciousness
  • received continuous positive airway pressure (CPAP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jaeyoung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 10, 2018

Study Start

August 17, 2018

Primary Completion

May 24, 2019

Study Completion

December 2, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Locations