Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient (OSAHS)

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

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

Study Overview

• Status: Unknown
• Conditions: Airway Obstruction; Difficult Intubation
• Intervention / Treatment: Diagnostic test: difficult tracheal intubation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • YAN SIYI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate or severe obstructive sleep apnea hypopnea syndrome, which means apnea-hypopnea index( AHI) >15/h and lowest SpO2(LSpO2)<85% in polysommographic test.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSAHS; patients with OSAHS, undergoing UPPP	Diagnostic test: difficult tracheal intubation; Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult Tracheal Intubation	Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view	1min After tracheal intubation

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Chair: Huan Zhang, MD, department of anesthesia

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: airway management; obstructive sleep apnea hypopnea syndrome; risk predictive model
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: XMLX201824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No