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Comparison Of The Effect Of Supine And Prone Position On The Ultrasonographic Airway Measurements

Primary Purpose

Airway Edema, Obstructive Sleep Apnea, Respiratory Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preoperative airway ultrasonography
postoperative airway ultrasonography
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Airway Edema focused on measuring airway edema, obstructive sleep apnea, respiratory complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:1-American Society of Anesthesiologists Physical Status Classification (ASA) I-II-III-IV risk group who will undergo Percutaneous Nephrolithotomy surgery

Exclusion Criteria:

  1. prone position contraindications
  2. history of maxillofacial deformity, tumor or trauma,
  3. difficult airway history
  4. decompensated cardiac, respiratory, hepatic, renal diseases
  5. cervical spine fracture
  6. Patients refusal -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    supine

    prone

    Arm Description

    operation in the supine position

    operation in the prone position

    Outcomes

    Primary Outcome Measures

    Preoperative Tongue thickness
    postoperative Tongue thickness1
    postoperative Tongue thickness2
    preoperative Tongue volume
    postoperative Tongue volume1
    postoperative Tongue volume2
    Preoperative Lateral parapharyngeal wall thickness
    postoperative Lateral parapharyngeal wall thickness1
    postoperative Lateral parapharyngeal wall thickness2
    Critical respiratory events

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2022
    Last Updated
    January 5, 2022
    Sponsor
    Ankara City Hospital Bilkent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05197400
    Brief Title
    Comparison Of The Effect Of Supine And Prone Position On The Ultrasonographic Airway Measurements
    Official Title
    A Prospective Randomized Comparison Of The Effect Of Supine And Prone Position On The Ultrasonographic Upper Airway Measurements And Postoperative Critical Respiratory Events
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2022 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara City Hospital Bilkent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Airway Edema, Obstructive Sleep Apnea, Respiratory Complication
    Keywords
    airway edema, obstructive sleep apnea, respiratory complications

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    supine
    Arm Type
    Active Comparator
    Arm Description
    operation in the supine position
    Arm Title
    prone
    Arm Type
    Active Comparator
    Arm Description
    operation in the prone position
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    preoperative airway ultrasonography
    Intervention Description
    Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    postoperative airway ultrasonography
    Intervention Description
    Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness
    Primary Outcome Measure Information:
    Title
    Preoperative Tongue thickness
    Time Frame
    Baseline, preoperative
    Title
    postoperative Tongue thickness1
    Time Frame
    postextubation
    Title
    postoperative Tongue thickness2
    Time Frame
    postoperative 2. hour]
    Title
    preoperative Tongue volume
    Time Frame
    Baseline, preoperative
    Title
    postoperative Tongue volume1
    Time Frame
    postextubation
    Title
    postoperative Tongue volume2
    Time Frame
    postoperative 2. hour
    Title
    Preoperative Lateral parapharyngeal wall thickness
    Time Frame
    Baseline, preoperative
    Title
    postoperative Lateral parapharyngeal wall thickness1
    Time Frame
    postextubation
    Title
    postoperative Lateral parapharyngeal wall thickness2
    Time Frame
    postoperative 2. hour
    Title
    Critical respiratory events
    Time Frame
    Within postoperative 2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:1-American Society of Anesthesiologists Physical Status Classification (ASA) I-II-III-IV risk group who will undergo Percutaneous Nephrolithotomy surgery Exclusion Criteria: prone position contraindications history of maxillofacial deformity, tumor or trauma, difficult airway history decompensated cardiac, respiratory, hepatic, renal diseases cervical spine fracture Patients refusal -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    betül güven aytaç, md
    Phone
    +905073578351
    Email
    drbguven@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ışıl karabeyoğlu, md
    Organizational Affiliation
    ankara ch bilkent
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    betül güven aytaç
    Organizational Affiliation
    Ankara CH bilkent
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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