NCT06448377

Brief Summary

The aim of our study is to observationally examine our unexpected difficult airway incidence and intervention times. In addition, it is aimed to discuss the clinical effect of a team specialized in airway intervention intervening in cases by call on the success of airway intervention. In this discussion, it is aimed to use the opinion-opposition method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

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

March 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

October 24, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 3, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

airway managementanesthesiaintubationdifficult airway

Outcome Measures

Primary Outcomes (1)

  • Successful endotracheal intubation rate in difficult airway

    The primary outcome of our study is the rate( in percent) of complication-free and successful endotracheal intubation performed by specialists or the airway team in unexpected difficult airway cases.

    During the intraoperative period of difficult intubation case

Secondary Outcomes (2)

  • The response time of the airway team to the case and the tools they used

    During the intraoperative period of difficult intubation case

  • airway intervention equipment

    During the intraoperative period of difficult intubation case

Study Arms (2)

Airway Team Group

In this group, the intervention time and methods used by the airway team will be evaluated in patients who have been called for airway assistance.

Procedure: VideolaryngoscopyProcedure: FOBProcedure: FOB+AintreeProcedure: Classic intubation with laryngoscopyProcedure: Others

Control Group

In this group, anesthesiologists' feedback on difficult airway cases will be received.

Procedure: VideolaryngoscopyProcedure: FOBProcedure: FOB+AintreeProcedure: Classic intubation with laryngoscopyProcedure: Others

Interventions

Situations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group.

Airway Team GroupControl Group
FOBPROCEDURE

Situations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group.

Also known as: endotracheal intubation with fiberoptic bronchoscope
Airway Team GroupControl Group
FOB+AintreePROCEDURE

Situations in which the practitioner performs endotracheal intubation using a Fiberoptic intubation via LMA with aintree catheter during airway intervention will be included in this group.

Also known as: Fiberoptic intubation via LMA with aintree catheter
Airway Team GroupControl Group

Situations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group.

Airway Team GroupControl Group
OthersPROCEDURE

Cases in which intubation cannot be performed, those who are awakened from anesthesia, or those in whom a surgical method is used for airway access will be included in this group.

Airway Team GroupControl Group

Eligibility Criteria

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

Unexpected difficult airway patients will be included in our study. These patients should need perioperative endotracheal intubation without signs of difficult airway in their airway evaluation scores, and the patients should be intervened by the anesthesiologists themselves or the airway team.

You may qualify if:

  • Patients who will be operated under general anesthesia at Kocaeli City Hospital or who require perioperative endotracheal intubation will be included in our study.
  • Operations performed within the study time period will be taken
  • Patients whose anesthesiologists call for help for difficult airway will be included in the study.
  • Patients between the ages of 18-65 will be included in the study.

You may not qualify if:

  • \- 1. Expected difficult airway patients (mallampati 3-4) and other patients with high difficult airway scores will not be included in the study.
  • \. Patients with difficult airway conditions but who will be awakened by giving up endotracheal intubation will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

Location

Related Publications (5)

  • Pandian V, Ghazi TU, He MQ, Isak E, Saleem A, Semler LR, Capellari EC, Brenner MJ. Multidisciplinary Difficult Airway Team Characteristics, Airway Securement Success, and Clinical Outcomes: A Systematic Review. Ann Otol Rhinol Laryngol. 2023 Aug;132(8):938-954. doi: 10.1177/00034894221123124. Epub 2022 Oct 2.

    PMID: 36189709BACKGROUND
  • Karamchandani K, Wheelwright J, Yang AL, Westphal ND, Khanna AK, Myatra SN. Emergency Airway Management Outside the Operating Room: Current Evidence and Management Strategies. Anesth Analg. 2021 Sep 1;133(3):648-662. doi: 10.1213/ANE.0000000000005644.

    PMID: 34153007BACKGROUND
  • Penketh J, Nolan JP. Airway management during cardiac arrest. Curr Opin Crit Care. 2023 Jun 1;29(3):175-180. doi: 10.1097/MCC.0000000000001033. Epub 2023 Mar 28.

    PMID: 37078613BACKGROUND
  • Mark LJ, Herzer KR, Cover R, Pandian V, Bhatti NI, Berkow LC, Haut ER, Hillel AT, Miller CR, Feller-Kopman DJ, Schiavi AJ, Xie YJ, Lim C, Holzmueller C, Ahmad M, Thomas P, Flint PW, Mirski MA. Difficult airway response team: a novel quality improvement program for managing hospital-wide airway emergencies. Anesth Analg. 2015 Jul;121(1):127-139. doi: 10.1213/ANE.0000000000000691.

    PMID: 26086513BACKGROUND
  • Koh W, Kim H, Kim K, Ro YJ, Yang HS. Encountering unexpected difficult airway: relationship with the intubation difficulty scale. Korean J Anesthesiol. 2016 Jun;69(3):244-9. doi: 10.4097/kjae.2016.69.3.244. Epub 2016 Jun 1.

    PMID: 27274369BACKGROUND

MeSH Terms

Interventions

Intubation, IntratrachealLaryngoscopyBro protein, Drosophila

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative TechniquesDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Officials

  • Ahmet YUKSEK, Md

    Kocaeli Cith 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

June 3, 2024

First Posted

June 7, 2024

Study Start

March 15, 2024

Primary Completion

September 15, 2024

Study Completion

October 15, 2024

Last Updated

October 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The data of the study participants can be requested from Kocaeli Provincial Health Directorate with an appropriate letter. It is unauthorized for responsible researchers to distribute these data.

Locations