Difficult Airway and Ultrasonographic Evaluation | NCT05347121

Studies
Difficult Airway and Ultrasonographic Evaluation

NCT05347121

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Apr 26, 2022Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Difficult Airway

Interventions

difficult airway

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2021Actual

Primary Completion Date

Sep 28, 2021Actual

Completion Date

Nov 3, 2021Actual

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

Apr 21, 2022

First Posted Date

Apr 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, it was planned to evaluate the preoperative neck ultrasonography measurements as a predictor of difficult airway in adult patients who will undergo elective surgery under general anesthesia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
difficult airway			Diagnostic Test: difficult airway

Interventions

Name	Type	Description	Arm Group Labels	Other Names
difficult airway	Diagnostic Test	ultrasonography of airway	difficult airway

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
epiglottis-skin thickness	epiglottis-skin thickness is a marker of difficult airway	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical condition I-II-III

Exclusion Criteria:

. Uncooperative patients,
pregnant women,
patients who have had head and neck trauma/surgery,
patients with a known history of difficult airway

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study included American Society of Anesthesiologists (ASA) physical status I-II-III, 120 patients over the age of 18 who would be operated under general anesthesia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli Üniversitesi		Kocaeli	Kocaeli̇	41000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided