Difficult Intubation in ObesityNCT05424289
The Predictive Value of Videoryngoscopy in Preoperative Airway Evaluation in Obese Patients
An observational study of Difficult Intubation in Obesity, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is the evaluation of preoperativevideolaryngoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Difficult Intubation in Obesity
- What is being tested?
- videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 20 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidate to elective surgery under general anesthesia obese patients BMI 30<
Who may be able to join
- Candidate to elective surgery under general anesthesia Body mass index (BMI) 30<
Who cannot join
- Subjects with suspect or ascertained malignancy of the nose, mouth, phayrx, or larynx that may interfere with tracheal intubation Subjects with tracheostomy Subjects candidate to elective awake intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology
Ankara, 06110
About this study
The aim of this study is the evaluation of preoperativevideolaryngoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population.
Videolaryngoscopy is a minimally invasive examination performed during difficult intubation evaluation but not used routinely . On the other hand, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific. An unexpected difficult or failed intubation at the induction of general anesthesia is a seriuos, and potentially fatal, emergency in anesthesia.
Read more
In literature, a correlation between anatomical and functional parameters highlighted by videolaryngoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor indagated. There is only some case reports related evaluation of diffucult airway by videolaryngoscopy .
If proven, this might give the Anesthestiologist further information about the expected difficulty of laryngoscopy and intubation, guiding a different anesthesiological strategy.
Read the detailed description
This is a prospective, single-center, observational study. Aim of this study is the evaluation of preoperative videolaryngoscopy as a predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population. Unexpected difficult of failed intubation is a serious, and potentially fatal, occurrence at the induction of general anesthesia. However, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific.
Routine airway evaluation will be performed by the same anesthesiologist for patients with a BMI above 30 who will undergo general anesthesia for scheduled surgery. In the preoperative operating room, these patients will undergo videoingoscopy and a POGO score will be applied (10% lidocaine will be sprayed on tonsil sites).
The investigators who do not performed preoperative videolaryngoscopy evaluation will be also collected data about the preoperative evaluation made by the Anesthesiologist as well as the effective difficulty of laryngoscopy and intubation encountered at the induction of general anaesthesia, expressed by the Cormack - Lehane scale and the Intubation Difficulty Scale (IDS) as described in literature.
General anesthesia will be performed as usual and will not be influenced by videolaryngoscopic evaluation as the Anesthesiologist will be blind to it, and he/she will be free to choose the best anesthesiological plan for his/her patient; whether an elective awake intubation will be chosen, this will exclude the patient from the study.
For safety reasons, the only exception to blindness is an expected difficulty of intubation (POGO score 0%) by senior anesthesiologist, based upon the physician's experience. In this case, he will talk to the Anesthesiologist about and the patient will be excluded from the study.
Preoperative data obtained by videolaryngoscopy and intraoperative data recorded by the Anesthesiologist will be matched and analyzed, to explore a possibile relationship.
- Conditions
- Difficult Intubation in Obesity
- Being tested
- videolaryngoscope
- Keywords
- difficult airway prediction, videolaryngoscopy, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaryngoscopeDevice
Videolaryngoscope is a high-resolution micro camera mounted on the tip of a curved blade connected to small portable digital monitor improves the view of the vocal cords
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty of tracheal videolaryngoscopy
The difficulty of tracheal laryngoscopy is described with the modified Cormack - Lehane Scale.
Measured: Intraoperative (single assessment)
Secondary outcomes (1)
Difficulty of tracheal intubation
The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS)
Measured: Intraoperative (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 May 2022
- Primary completion14 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Difficult Intubation in ObesityStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424289
- Sponsor's protocol ID
- SBU 2022
- Status last verified
- May 2024
- First submitted
- 15 Jun 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Utada S, Okano H, Miyazaki H, Niida S, Horiuchi H, Suzuki N, Otsuka T, Furuya R. Awake intubation with videolaryngoscopy and fiberoptic bronchoscope. Clin Case Rep. 2022 Jan 11;10(1):e05274. doi: 10.1002/ccr3.5274. eCollection 2022 Jan.
PubMed 35035964Heinrich S, Birkholz T, Irouschek A, Ackermann A, Schmidt J. Incidences and predictors of difficult laryngoscopy in adult patients undergoing general anesthesia : a single-center analysis of 102,305 cases. J Anesth. 2013 Dec;27(6):815-21. doi: 10.1007/s00540-013-1650-4. Epub 2013 Jun 9.
PubMed 23748552Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PubMed 6507827Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Videoryngoscopy in Preoperative Airway Evaluation in Obese Patients
- ClinicalTrials.gov ID
- NCT05424289
- Acronym / sponsor ID
- SBU 2022
- Conditions
- Difficult Intubation in Obesity
- Keywords
- difficult airway prediction, videolaryngoscopy, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 21 Jun 2022 (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 this study is the evaluation of preoperativevideolaryngoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population.
Videolaryngoscopy is a minimally invasive examination performed during difficult intubation evaluation but not used routinely . On the other hand, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific. An unexpected difficult or failed intubation at the induction of general anesthesia is a seriuos, and potentially fatal, emergency in anesthesia.
In literature, a correlation between anatomical and functional parameters highlighted by videolaryngoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor indagated. There is only some case reports related evaluation of diffucult airway by videolaryngoscopy .
If proven, this might give the Anesthestiologist further information about the expected difficulty of laryngoscopy and intubation, guiding a different anesthesiological strategy.
Detailed description
This is a prospective, single-center, observational study. Aim of this study is the evaluation of preoperative videolaryngoscopy as a predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population. Unexpected difficult of failed intubation is a serious, and potentially fatal, occurrence at the induction of general anesthesia. However, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific.
Routine airway evaluation will be performed by the same anesthesiologist for patients with a BMI above 30 who will undergo general anesthesia for scheduled surgery. In the preoperative operating room, these patients will undergo videoingoscopy and a POGO score will be applied (10% lidocaine will be sprayed on tonsil sites).
The investigators who do not performed preoperative videolaryngoscopy evaluation will be also collected data about the preoperative evaluation made by the Anesthesiologist as well as the effective difficulty of laryngoscopy and intubation encountered at the induction of general anaesthesia, expressed by the Cormack - Lehane scale and the Intubation Difficulty Scale (IDS) as described in literature.
General anesthesia will be performed as usual and will not be influenced by videolaryngoscopic evaluation as the Anesthesiologist will be blind to it, and he/she will be free to choose the best anesthesiological plan for his/her patient; whether an elective awake intubation will be chosen, this will exclude the patient from the study.
For safety reasons, the only exception to blindness is an expected difficulty of intubation (POGO score 0%) by senior anesthesiologist, based upon the physician's experience. In this case, he will talk to the Anesthesiologist about and the patient will be excluded from the study.
Preoperative data obtained by videolaryngoscopy and intraoperative data recorded by the Anesthesiologist will be matched and analyzed, to explore a possibile relationship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidate to elective surgery under general anesthesia obese patients BMI 30<
Key inclusion criteria (1 listed)
- Candidate to elective surgery under general anesthesia Body mass index (BMI) 30<
Key exclusion criteria (1 listed)
- Subjects with suspect or ascertained malignancy of the nose, mouth, phayrx, or larynx that may interfere with tracheal intubation Subjects with tracheostomy Subjects candidate to elective awake intubation
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 |
|---|---|---|
| videolaryngoscopeVideolaryngoscope is a high-resolution micro camera mounted on the tip of a curved blade connected to small portable digital monitor improves the view of the vocal cords | Device | – |
Primary outcome
Difficulty of tracheal videolaryngoscopy
Time frame: Intraoperative (single assessment)
The difficulty of tracheal laryngoscopy is described with the modified Cormack - Lehane Scale.
1 secondary outcome
Difficulty of tracheal intubation
Time frame: Intraoperative (single assessment)
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 29 May 2024.
- Background: PubMed 35035964Utada S, Okano H, Miyazaki H, Niida S, Horiuchi H, Suzuki N, Otsuka T, Furuya R. Awake intubation with videolaryngoscopy and fiberoptic bronchoscope. Clin Case Rep. 2022 Jan 11;10(1):e05274. doi: 10.1002/ccr3.5274. eCollection 2022 Jan.
- Results publication: PubMed 23748552Heinrich S, Birkholz T, Irouschek A, Ackermann A, Schmidt J. Incidences and predictors of difficult laryngoscopy in adult patients undergoing general anesthesia : a single-center analysis of 102,305 cases. J Anesth. 2013 Dec;27(6):815-21. doi: 10.1007/s00540-013-1650-4. Epub 2013 Jun 9.
- Results publication: PubMed 6507827Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Results publication: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Intubation in Obesity, run by Diskapi Teaching and Research 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 1 inclusion and 1 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 29 May 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?
Difficulty of tracheal videolaryngoscopy (time frame: Intraoperative (single assessment)). 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 NCT05424289, which also lists 4 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 29 May 2024.