Clinical trial

High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy

Recruiting now · Not applicable · 1 countries · Registry ID NCT07159022

Recruiting nowNot applicableInterventional

What this study is about

During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia. Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersAccepted

ConditionHigh Flow Nasal Cannula, Body Roundness Index

Full registry criteria

Inclusion Criteria: * ASA class ≤Ⅲ * Visceral obesity（body mass index≥28 and BRI ≥5.46） * Patients who will undergo sedated gastroscopy Exclusion Criteria: * Life-threatening heart disease or acute myocardial infarction within 6 weeks * Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema * Upper respiratory tract infection * Presence of tracheostomy * Nasal or nasopharyngeal diseases * Coagulation disorders or a tendency of nose bleeding * Pregnancy * Recent (within 1 week) thoracic surgery * Emergent procedure or surgery * Allergy to drugs used during the procedure * Unwillingness to participate in the study

Treatments and study arms

High Flow Nasal Cannula Oxygenation

Procedure

High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%

Face Mask Oxygenation

Procedure

conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute

Primary outcomes

Incidence of hypoxiaFrom sedation with propofol to the end of the gastroscopy

SpO2\<90%

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Zhongshan Hospitla🇨🇳 Shanghai, China

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