NCT04140981

Brief Summary

In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

October 24, 2019

Last Update Submit

December 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cormack Lehane classification

    Laryngoscopic evaluation according to Cormack Lehane classification

    during the intubation period

Secondary Outcomes (1)

  • ultrasonographic measurement

    15 min before the operation

Study Arms (4)

group 1

difficult intubation according to antropometric measurements

Device: ultrasounography

group 2

not difficult intubation according to antropometric measurements

Device: ultrasounography

group 3

difficult intubation according to ultrasound measurements

Device: ultrasounography

group 4

not difficult intubation according to ultrasound measurements

Device: ultrasounography

Interventions

in preoperative period, airway ultrasounagraphy for all patients will be made

group 1group 2group 3group 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia

You may qualify if:

  • patients under general anesthesia
  • ASA 1-2-3

You may not qualify if:

  • Patients who will undergo emergency surgery,
  • pregnant women,
  • children,
  • patients who may have difficulty in airway management due to cervical instability,
  • patients with trauma or malignancy in the neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale Univercity Faculty of Medicine Hospital

Kırıkkale, 71450, Turkey (Türkiye)

Location

Study Officials

  • Kevser Peker

    Kırıkkale University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assitant professor

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations