COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhejiang University

About this trial

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18≤ Age ≤70.

BMI ≥ 28 kg/m².

The ASA classification ranges from I to II.

Patients have signed the informed consent form.

Disqualifiers

Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.

Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).

Profound renal insufficiency necessitating preoperative dialysis.

A confirmed severe liver dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • the COMBO Endoscopy Oropharyngeal Airway Group

    Device

    Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

  • Regular Nasal Cannula

    Device

    Using regular nasal cannula for oxygenation.

Treatment groups

580 Participants
are divided into 2 treatment groups
Group A: the COMBO Endoscopy Oropharyngeal Airway GroupExperimental treatment 1 intervention
Group B: Regular Nasal Cannula GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxia

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

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

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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