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Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT

ConditionsHypoxemiaAirway Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQianfoshan Hospital

About this trial

This multicenter, prospective, randomized controlled trial aims to evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia in 1,518 adult patients (ASA I-II, aged 18-80 years) undergoing elective sedated gastrointestinal endoscopy. Patients are randomized 1:1 to receive either the MOPA (which integrates oxygen delivery, PETCO₂ monitoring, and airway support) or conventional nasal cannula with standard mouthpiece. The primary endpoint is the incidence of hypoxemia (75% ≤ SpO₂ \< 90% for \<60 seconds) during the procedure. Secondary outcomes include severe hypoxemia, hypercapnia, PETCO₂ monitoring success, airway interventions, adverse events, and satisfaction scores. The study is conducted across 29 centers in China, with centralized randomization via an EDC system, blinded outcome assessment, and statistical analysis using a two-sided alpha of 0.05 (power 90%). Results are expected to provide high-level evidence for optimizing airway management during sedated endoscopy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-80 years;

BMI: 18-30 kg/m²;

ASA class I-II;

Scheduled to undergo elective sedated gastrointestinal endoscopy;

Disqualifiers

Diagnosed respiratory diseases, including asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, moderate or severe obstructive sleep apnea (OSA), pulmonary embolism, pulmonary edema, lung cancer, or upper respiratory tract infection, etc.;

Coagulation disorders, tendency for oral/nasal bleeding, mucosal injury, or space-occupying lesions;

Severe cardiac insufficiency (≤4 MetS);

Severe renal insufficiency (acute kidney injury [AKI] or chronic kidney disease [CKD] stage 4 or higher);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Novel Multifunctional Oropharyngeal Airway

    Device

    The Novel Multifunctional Oropharyngeal Airway is an integrated airway device designed for sedated gastrointestinal endoscopy. It combines a modified mouthpiece, an oropharyngeal airway, an oxygen delivery channel, and a PETCO₂ sampling port into a single unit. The device maintains upper airway patency by preventing tongue prolapse, delivers oxygen directly to the pharynx near the glottis for more efficient oxygenation, and enables continuous real-time capnography monitoring. It is made of soft medical-grade material with anatomical curvature and depth markings to minimize mucosal injury and patient discomfort. The MOPA also reserves an interface for emergency jet ventilation if needed. It is inserted under sedation and allows the endoscope to pass smoothly through its central channel without obstruction.

Treatment groups

1,518 Participants
are divided into 2 treatment groups
Group A: Experimental group: Novel multifunctional oropharyngeal airway groupExperimental treatment 1 intervention
Group B: Control group: Conventional mouthpiece groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)

Incidence of intraoperative hypoxemia (75% ≤ SpO₂ \< 90%, duration \< 60 seconds)

Time frame
Perioperative

Secondary outcomes

1

Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).

Incidence of severe hypoxemia (SpO₂ \< 75% OR 75% ≤ SpO₂ \< 90% lasting ≥ 60 seconds).

Time frame
Perioperative
2

PETCO₂ monitoring success rate

proportion of participants from whom a clear, continuous PETCO₂ waveform is obtained

Time frame
Perioperative
3

Detection rate of hypoventilation events

apnea (waveform disappearance ≥ 15-20 seconds) / bradypnea (respiratory rate \< 8 breaths/min lasting ≥ 30 seconds), etc.; and the proportion of early recognition before SpO₂ decline, as well as the advanced warning time (data exported from the monitor)

Time frame
Perioperative
4

Incidence of hypercapnia

PETCO₂ \> 50 mmHg (or \> 45 mmHg) lasting ≥ 30 seconds

Time frame
Perioperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qianfoshan Hospital

Lead sponsor

Source ClinicalTrials.gov

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