- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448377
Initiation of Airway Code: the Role of the Airway Team in Unexpected Difficult Airways
Study Overview
Status
Detailed 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. 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. Consequently, some unexpected difficult airway cases are encountered, and their management continues to be a subject of new research in the literature.
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. 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. 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 teams intervention in unexpected difficult airway situations within the operating room, using a pro-con debate method.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Izmıt
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Kocaeli, Izmıt, Turkey, 41100
- Kocaeli City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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Situations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group.
Situations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group.
Other Names:
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.
Other Names:
Situations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group.
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.
|
|
Control Group
In this group, anesthesiologists' feedback on difficult airway cases will be received.
|
Situations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group.
Situations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group.
Other Names:
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.
Other Names:
Situations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Successful endotracheal intubation rate in difficult airway
Time Frame: During the intraoperative period of difficult intubation case
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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.
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During the intraoperative period of difficult intubation case
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The response time of the airway team to the case and the tools they used
Time Frame: During the intraoperative period of difficult intubation case
|
In this section, the interventions performed by the airway team will be compared with the control group.
The duration( time in minutes) of the intervention and the different airway tools used will be compared numerically.
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During the intraoperative period of difficult intubation case
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airway intervention equipment
Time Frame: During the intraoperative period of difficult intubation case
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To determine the most commonly used assistive devices (type) in airway intervention and to compare their frequencies ( in percent) in two different defined groups.
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During the intraoperative period of difficult intubation case
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet YUKSEK, Md, Kocaeli Cith Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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