The Predictive Value of Videoryngoscopy in Preoperative Airway Evaluation in Obese Patients

NCT ID: NCT05424289

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-20

Brief Summary

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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

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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

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Difficult Intubation in Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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videolaryngoscope

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidate to elective surgery under general anesthesia Body mass index (BMI) 30\<

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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derya özkan

Professor MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35035964 (View on PubMed)

Heinrich 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.

Reference Type RESULT
PMID: 23748552 (View on PubMed)

Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

Reference Type RESULT
PMID: 6507827 (View on PubMed)

Adnet 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.

Reference Type RESULT
PMID: 9416711 (View on PubMed)

Other Identifiers

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SBU 2022

Identifier Type: -

Identifier Source: org_study_id

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