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

NCT05424289 | Completed DMC FDA Device

• 1 other identifier: SBU 2022
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Difficult Intubation in Obesity

Keywords

difficult airway prediction, videolaryngoscopy, obesity

Outcome Measures

Primary Outcomes (1)

• Difficulty of tracheal videolaryngoscopy

  The difficulty of tracheal laryngoscopy is described with the modified Cormack - Lehane Scale.

  Intraoperative (single assessment)

Secondary Outcomes (1)

• Difficulty of tracheal intubation

  Intraoperative (single assessment)

Interventions

videolaryngoscope DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Candidate to elective surgery under general anesthesia obese patients BMI 30\<

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

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

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 35035964 BACKGROUND

• 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.

  PMID: 23748552 RESULT

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

  PMID: 6507827 RESULT

• 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.

  PMID: 9416711 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: May 1, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)