Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

BMI ≥ 35 kg/m².

Patients undergoing gastroscopy or gastrointestinal endoscopy.

The estimated duration of the procedure does not exceed 45 minutes.

Disqualifiers

Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.

Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).

Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.

Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.

Trial design

Design model

Parallel

Treatments tested in this trial

  • COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

    Device

    Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients

  • High-Flow Nasal Cannula Oxygenation

    Device

    In this group, patients use high-flow nasal cannula oxygenation

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula OxygenationExperimental treatment 1 intervention
Group B: High-Flow Nasal Cannula OxygenationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxemia

75% ≤ SpO2 \< 90% for \<60 s

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary outcomes

1

The incidence of sub-clinical respiratory depression

90% ≤ SpO2 \< 95%

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
2

The incidence of severe hypoxaemia

SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other outcomes

1

The incidence of other adverse events

Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours.

Sponsors and contacts

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