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NCT04506346 Clinical Trial

Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient

Airway Obstruction Clinical Trial

— OSAHS  

Official title:
Risk Prediction of Difficult Tracheal Intubation in Obstructive Sleep Apnea Hypopnea Syndrome Patient (OSAHS) Undergoing Uvulo-palato-pharyngoplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04506346
Other study ID # XMLX201824
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date December 31, 2021

Study information
Verified date August 2020
Source Beijing Tsinghua Chang Gung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)

Description:

OSAHS patients are high risk group of difficult tracheal intubation. In clinical application, unexpected difficult tracheal intubation is not rare. Difficult airway is a significant problem to these patients and the physicans in terms of mortality and morbidity.

This study collects risk factors as physical examinations（including modified Mallampati grade, neck circumference, lateral clinical craniofacial assessment and body mass index ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using statistics method, predictive model to manage risks would be established.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- diagnosed as OSAHS.

- receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital

- ASA grade I or II

Exclusion Criteria:

- ASA grade III or above

- had received UPPP

- had fore-teeth loosed

- obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal cord paralysis.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• difficult tracheal intubation
Grade ? or ? according to Cormach-Lehane Grading of laryngoscopic view

Locations
Country Name City State
China YAN SIYI Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difficult Tracheal Intubation Grade ? or ? according to Cormach-Lehane Grading of laryngoscopic view 1min After tracheal intubation
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