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NCT Number: NCT07159022

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

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.

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Key information

Conditions

High Flow Nasal Cannula Body Roundness Index

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospitla

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Incidence of hypoxia

    Time frame: From sedation with propofol to the end of the gastroscopy

    SpO2<90%

Secondary outcomes

  1. Incidence of subclinical respiratory depression

    Time frame: From sedation with propofol to the end of the gastroscopy

    90%≤SpO2<95%

  2. Severe hypoxia

    Time frame: From sedation with propofol to the end of the gastroscopy

    SpO2<75% for any duration or 75%≤SpO2<90% for >60 s

  3. Serious cardiac events

    Time frame: Through gastroscopy completion, an average of 10-15 minutes

    Hypotension: Mean arterial pressure (MAP) < 65 mmHg; hypertension: MAP > 90 mmHg

  4. Serious adverse respiratory events

    Time frame: Through gastroscopy completion, an average of 10-15 minutes

    Apnea, tracheospasm, larynx spasm

Study contacts

Contact information is provided by the study sponsor or research team.

Wenling Zhao

CONTACT

[email protected]

+86-18321299017

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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