Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06265064
Other study ID # KhonKaenUniversity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2022
Est. completion date October 31, 2023

Study information

Verified date February 2024
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia. The main question[s] it aims to answer are: - Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients? - Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia. Participants who undergoing to elective surgery under general anesthesia will - Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation) - In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion. If there is a comparison group: Researchers will compare obese patients with/without high STOP bang score >=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference > 42 cm, Thyromental distance < 6 cm)to prediction difficult mask ventilation


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BMI = 25 kg/m2 - Age > 18 years old - undergoing elective surgery under general anesthesia with endotracheal intubation Exclusion Criteria: - History of difficult mask and intubation - Maxillofacial or upper airway malformation - History of C-spine disease such as trauma, degeneration - Pregnancy - Rapid sequence induction technique

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
STOP-Bang score >= 3 with factors predicting difficult intubation
patients with STOP-Bang score >= 3 with Mallampati score = 3 or neck circumference >42 cm or mentothyroid distance <6 cm

Locations

Country Name City State
Thailand KhonKaen University Nai Muang Khonkaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult mask ventilation Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is = 3, it signifies difficult mask ventilation After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.
Secondary Resipiratory complication Airway trauma
Desaturation Spo2<90% in 2 minutes
Regurgitation
Aspiration
during mask ventilation until the completion of intubation.
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2