NCT06596889

Brief Summary

In this study, investigators will research the types and incidence rates of airway complications seen in the perioperative period during airway management. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
870

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 15, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

September 11, 2024

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of airway complications seen in the induction of anesthesia.

    The incidence of complications (mucosal bleeding, tooth damage, etc.) that may occur during induction of anesthesia with different airway devices will be investigated.

    The first 15 minutes during induction of anesthesia

Study Arms (2)

Not any equipment

Control group

Procedure: Successful airway management

Other types of equipment

Brand new oral airways

Procedure: Successful airway management

Interventions

* Types of equipment: Traditional oral airways, new airways, etc. * Professional experience of the airway management practitioner (in years). * If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts will be recorded separately for each patient.

Not any equipmentOther types of equipment

Eligibility Criteria

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

The study was prospective and observational. There is no grouping. Oral and written informed consent will be obtained from the patients in the preoperative ward or in the preoperative preparation room of the operating room. Patients scheduled for elective operation under general anesthesia whose consents were obtained will be included in the study. Airway management techniques and equipment used will not be interfered with. After the patient's airway management is completed: the following data will be recorded. * Types of equipment: laryngoscopes, face masks, oral airways, styli, plugs, etc. * Professional experience of the airway management practitioner (in years). * If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts.

You may qualify if:

  • Patients between the ages of 18 and 75.
  • Patients who will undergo elective surgery.
  • Patients to be operated under general anesthesia.
  • Patients without difficult airway markers

You may not qualify if:

  • Patients to be operated with emergency surgical indication.
  • Patients to be operated with regional anesthesia.
  • Patients with expected difficult airway markers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kocaeli City Hospital

Kocaeli, 41100, Turkey (Türkiye)

Location

University of Health Sciences Sanliurfa Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

Study Officials

  • Mehmet Yılmaz

    Kocaeli City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

August 15, 2024

Primary Completion

February 15, 2025

Study Completion

March 15, 2025

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations