Initiation of Airway Code: The Role of the Airway Team in Unexpected Difficult Airways

Airway Management Clinical Trial

Official title:

Initiation of Airway Code: The Role of the Airway Team in Unexpected Difficult Airways

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448377
• Other study ID #: 2025-25
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: June 2024
• Source: Kocaeli City Hospital
• Contact: Ahmet YUKSEK, MD
• Phone: 05326580351
• Email: mdayuksek[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Initiation of Airway Code: The Role of the Airway Team in Unexpected Difficult Airways The incidence of difficult airway is approximately 1 in 1000 cases and poses a significant perioperative risk to patients(1). Various classifications, guidelines, and approaches have been developed to identify patients with difficult airways. However, even the most well-known classifications are not 100% successful in predicting difficult airways(2). Consequently, some unexpected difficult airway cases are encountered, and their management continues to be a subject of new research in the literature(3). In situations involving difficult airways, having the same team respond to every case may pose a potential obstacle to the distribution of experience and responsibilities among other clinical staff(4,5). However, it is undeniable that experienced anesthetists are more successful in airway management, and the importance of airway-related training cannot be overstated. Similar to the code blue protocol used during cardiac arrests, the intervention of a trained external team in crisis situations, utilizing familiar equipment and applying data from previous cases for quality improvement, can provide significant benefits in airway management akin to those seen in cardiac arrests(6,7). This approach could also potentially enhance patient safety in internal medicine and surgical wards, as well as in certain intensive care units, where familiarity with airway management is limited. This study aims to discuss the positive and negative impacts of the airway team's intervention in unexpected difficult airway situations within the operating room, using a pro-con debate method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients who will be operated under general anesthesia at Kocaeli City Hospital or who require perioperative endotracheal intubation will be included in our study.

2. Operations performed within the study time period will be taken

3. Patients whose anesthesiologists call for help for difficult airway will be included in the study.

4. Patients between the ages of 18-65 will be included in the study.

Exclusion Criteria:

• 1. Expected difficult airway patients (mallampati 3-4) and other patients with high difficult airway scores will not be included in the study.

2. Patients with difficult airway conditions but who will be awakened by giving up endotracheal intubation will not be included in the study.

Related Conditions & MeSH terms

• Airway Management
• Intubation;Difficult
• Unexpected Difficult Airway

Intervention

Procedure:
• Videolaryngoscopy
Situations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group.
• FOB
Situations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group.
• FOB+Aintree
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.
• Classic intubation with laryngoscopy
Situations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group.
• Others
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.

Locations

Country	Name	City	State
Turkey	Kocaeli City Hospital	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful endotracheal intubation rate in difficult airway	The primary outcome of our study is the rate 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	The response time of the airway team to the case and the tools they used	In this section, the interventions performed by the airway team will be compared with the control group. The duration of the intervention and the different airway tools used will be compared numerically.	During the intraoperative period of difficult intubation case
Secondary	airway intervention equipment	To determine the most commonly used assistive devices in airway intervention and to compare their frequencies in two different defined groups.	During the intraoperative period of difficult intubation case