Unexpected Difficult AirwayNCT06448377
Initiation of Airway Code: the Role of the Airway Team in Unexpected Difficult Airways
An observational study of Unexpected Difficult Airway and Intubation;Difficult, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unexpected Difficult Airway, Intubation;Difficult, Airway Management
- What is being tested?
- Videolaryngoscopy, FOB and FOB+Aintree
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Videolaryngoscopy, FOB, FOB+Aintree, Classic intubation with laryngoscopy, Others
- Keywords
- airway management, anesthesia, intubation, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopyProcedure or surgery
Situations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group.
FOBProcedure or surgery
Also called endotracheal intubation with fiberoptic bronchoscope
Situations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group.
FOB+AintreeProcedure or surgery
Also called Fiberoptic intubation via LMA with aintree catheter
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 laryngoscopyProcedure or surgery
Situations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group.
OthersProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Videolaryngoscopy; Procedure: FOB; Procedure: FOB+Aintree; Procedure: Classic intubation with laryngoscopy; Procedure: Others | |
| Control Group | In this group, anesthesiologists' feedback on difficult airway cases will be received. Receives: Procedure: Videolaryngoscopy; Procedure: FOB; Procedure: FOB+Aintree; Procedure: Classic intubation with laryngoscopy; Procedure: Others |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: During the intraoperative period of difficult intubation case
airway intervention equipment
To determine the most commonly used assistive devices (type) in airway intervention and to compare their frequencies ( in percent) in two different defined groups.
Measured: During the intraoperative period of difficult intubation case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start15 Mar 2024
- Primary completion15 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unexpected Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmet YUKSEK, Md, Principal investigator, Kocaeli Cith Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448377
- Sponsor's protocol ID
- 2025-25
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36189709Karamchandani 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.
PubMed 34153007Penketh 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.
PubMed 37078613Mark 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.
PubMed 26086513Koh 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.
PubMed 27274369
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Airway Code: the Role of the Airway Team in Unexpected Difficult Airways
- ClinicalTrials.gov ID
- NCT06448377
- Acronym / sponsor ID
- 2025-25
- Keywords
- airway management, anesthesia, intubation, difficult airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway Team Group | – | Procedure: Videolaryngoscopy, Procedure: FOB, Procedure: FOB+Aintree, Procedure: Classic intubation with laryngoscopy, Procedure: OthersIn this group, the intervention time and methods used by the airway team will be evaluated in patients who have been called for airway assistance. |
| Control Group | – | Procedure: Videolaryngoscopy, Procedure: FOB, Procedure: FOB+Aintree, Procedure: Classic intubation with laryngoscopy, Procedure: OthersIn this group, anesthesiologists' feedback on difficult airway cases will be received. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideolaryngoscopySituations in which the practitioner performs endotracheal intubation using a videolaryngoscope during airway intervention will be included in this group. | Procedure or surgery | Airway Team Group, Control Group |
| FOBAlso: endotracheal intubation with fiberoptic bronchoscopeSituations in which the practitioner performs endotracheal intubation using a fiberoptic bronchoscope during airway intervention will be included in this group. | Procedure or surgery | Airway Team Group, Control Group |
| FOB+AintreeAlso: Fiberoptic intubation via LMA with aintree catheterSituations 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. | Procedure or surgery | Airway Team Group, Control Group |
| Classic intubation with laryngoscopySituations in which the practitioner performs endotracheal intubation using a macintosh laryngoscope during airway intervention will be included in this group. | Procedure or surgery | Airway Team Group, Control Group |
| OthersCases 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. | Procedure or surgery | Airway Team Group, Control Group |
Primary outcome
Successful endotracheal intubation rate in difficult airway
Time frame: During the intraoperative period of difficult intubation case
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.
2 secondary outcomes
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
airway intervention equipment
Time frame: During the intraoperative period of difficult intubation case
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 36189709Pandian 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.
- Background: PubMed 34153007Karamchandani 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.
- Background: PubMed 37078613Penketh 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.
- Background: PubMed 26086513Mark 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.
- Background: PubMed 27274369Koh 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet YUKSEK, Md principal investigator
Kocaeli Cith Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexpected Difficult Airway and Intubation;Difficult, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful endotracheal intubation rate in difficult airway (time frame: During the intraoperative period of difficult intubation case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.