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Active, not recruitingNCT06596889Updated Oct 3, 2024

The Effect of Assistive Airway Equipment on Intubation

An observational study in Airway Management and Airway Complication of Anaesthesia, sponsored by Kocaeli City Hospital. Active, not recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Kocaeli City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
870
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Complications related to airway management rarely occur in the operating room; however, these complications can lead to life-threatening situations. There are many studies on the types and incidence rates of airway management complications in the perioperative period. However, although the types and incidence rates of airway complications have been investigated in these studies, the effect of airway equipment used in airway management on complications has not been investigated. There are many equipment used in airway management. Laryngoscopes, face masks, oral airway devices and many assistant airway management devices are used as basic equipment. Different airway equipment may be used in each center in each case. There is no standard between centers in this regard.

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

02

Conditions studied

  • Airway Management
  • Airway Complication of Anaesthesia
03

In context

Lead sponsor

Kocaeli City Hospital is the lead sponsor of 38 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients to be operated with emergency surgical indication.
  2. Patients to be operated with regional anesthesia.
  3. Patients with expected difficult airway markers.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
870 participants (estimated)
Patient registry
No

Groups and cohorts

  • Not any equipment

    Control group

    Procedure: Successful airway management

  • Other types of equipment

    Brand new oral airways

    Procedure: Successful airway management

Interventions

  • ProcedureSuccessful airway management

    * 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.

06

What researchers measure

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.

    Time frame: The first 15 minutes during induction of anesthesia

07

Study locations

2 sites
  • Kocaeli City Hospital
    Kocaeli, 41100, Turkey
  • University of Health Sciences Sanliurfa Mehmet Akif Inan Training and Research Hospital
    Sanliurfa, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06596889
Lead sponsor
Kocaeli City Hospital
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Aug 15, 2024
Primary completion
Feb 15, 2025 (estimated)
Completion
Mar 15, 2025 (estimated)
Last update
Oct 3, 2024

Study contacts

Mehmet Yılmaz
principal investigator · Kocaeli City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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