NCT05197400

Brief Summary

The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema. The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 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

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 5, 2022

Last Update Submit

January 13, 2025

Conditions

Airway EdemaObstructive Sleep ApneaRespiratory Complication

Keywords

airway edemaobstructive sleep apnearespiratory complications

Outcome Measures

Primary Outcomes (10)

  • Preoperative Tongue thickness

    Baseline, preoperative

  • postoperative Tongue thickness1

    postextubation

  • postoperative Tongue thickness2

    postoperative 2. hour]

  • preoperative Tongue volume

    Baseline, preoperative

  • postoperative Tongue volume1

    postextubation

  • postoperative Tongue volume2

    postoperative 2. hour

  • Preoperative Lateral parapharyngeal wall thickness

    Baseline, preoperative

  • postoperative Lateral parapharyngeal wall thickness1

    postextubation

  • postoperative Lateral parapharyngeal wall thickness2

    postoperative 2. hour

  • Critical respiratory events

    Within postoperative 2 hours

Study Arms (2)

supine

ACTIVE COMPARATOR

operation in the supine position

Diagnostic Test: preoperative airway ultrasonographyDiagnostic Test: postoperative airway ultrasonography

prone

ACTIVE COMPARATOR

operation in the prone position

Diagnostic Test: preoperative airway ultrasonographyDiagnostic Test: postoperative airway ultrasonography

Interventions

preoperative airway ultrasonographyDIAGNOSTIC_TEST

Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness

pronesupine
postoperative airway ultrasonographyDIAGNOSTIC_TEST

Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness

pronesupine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • prone position contraindications
  • history of maxillofacial deformity, tumor or trauma,
  • difficult airway history
  • decompensated cardiac, respiratory, hepatic, renal diseases
  • cervical spine fracture
  • Patients refusal -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • ışıl karabeyoğlu, md

    ankara ch bilkent

    PRINCIPAL INVESTIGATOR

  • betül güven aytaç

    Ankara CH bilkent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anaestesia and reanimation

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

January 15, 2025

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)