The Effect of Assistive Airway Equipment on Intubation

The Effect of Assistive Airway Equipment on Intubation-Related Events in the Perioperative Period

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Airway Management; Airway Complication of Anaesthesia
• Intervention / Treatment: Procedure: Successful airway management

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.

• Study Type: Observational
• Enrollment (Estimated): 870

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Other types of equipment; Brand new oral airways	Procedure: Successful 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.
Not any equipment; Control group	Procedure: Successful 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kocaeli City Hospital
• Investigators: Principal Investigator: Mehmet Yılmaz, Kocaeli City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-87

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No