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

NCT07623863 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2026(086)
• Study Type: interventional
• Target: 1,518
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypoxemia; Airway Management

Keywords

Novel multifunctional oropharyngeal airway; Capnography / PETCO₂ monitoring; Airway management; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

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

  Perioperative

Secondary Outcomes (8)

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

  Perioperative

• PETCO₂ monitoring success rate

  Perioperative

• Detection rate of hypoventilation events

  Perioperative

• Incidence of hypercapnia

  Perioperative

• Incidence of adverse events

  Perioperative

Study Arms (2)

Experimental group: Novel multifunctional oropharyngeal airway group

EXPERIMENTAL

Before anesthesia, oxygen is administered via nasal cannula at 3-4 L/min, and the dedicated mouthpiece of the novel multifunctional oropharyngeal airway is inserted. After anesthesia induction and before gastroscope insertion, the anesthesiologist places the novel multifunctional oropharyngeal airway through the side of the mouthpiece and connects the oxygen supply device of the airway to deliver oxygen. The PETCO₂ sampling port of the airway is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. Insertion and fixation of the airway are completed under sedation to avoid patient discomfort.

Device: Novel Multifunctional Oropharyngeal Airway

Control group: Conventional mouthpiece group

NO INTERVENTION

Before anesthesia, oxygen is administered via nasal cannula at 3-4 L/min, and a conventional mouthpiece is inserted. The PETCO₂ sampling port of the nasal cannula is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. After anesthesia induction, the gastroscopy is completed without using an oropharyngeal airway.

Interventions

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.

Experimental group: Novel multifunctional oropharyngeal airway group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• BMI: 18-30 kg/m²;
• ASA class I-II;
• Scheduled to undergo elective sedated gastrointestinal endoscopy;
• Willing to participate in this study and able to provide written informed consent.

You may not qualify if:

• 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);
• Severe hepatic insufficiency (Child-Pugh class C or worse);
• Planned therapeutic endoscopy (e.g., polypectomy, endoscopic mucosal resection \[EMR\], or other therapeutic procedures);
• Pregnancy or breastfeeding;
• Allergy to the study drugs;
• Emergency surgery;
• Daily alcohol intake ≥60 grams;
• History of psychiatric disorders: e.g., depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease;
• Myasthenia gravis;
• Participation in other related clinical trials within the past 3 months;
• Refusal to participate.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianbo Wu, Doctoral

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianbo wu

CONTACT

18560083793; jianbowu@sdu.edu.cn

琦 尤

CONTACT

19553100910; 312011097@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study adopts EDC system-based central randomization, fully integrating the three processes of random allocation sequence generation, participant enrollment and registration, and intervention assignment into a unified EDC platform. Strict segregation of duties and allocation concealment are achieved through graded user permissions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study adopts a multicenter, randomized, parallel-controlled design. After completing screening and signing informed consent, eligible participants are randomly assigned in a 1:1 ratio to either the experimental group or the control group through a central randomization system. The randomization sequence is generated by an independent statistician, and each study center obtains the allocation results via the system. 1. Experimental group: Novel multifunctional oropharyngeal airway group 2. Control group: Conventional mouthpiece group Except for the different airway management strategies, all other aspects-including anesthesia regimen, sedation target, monitoring parameters, and intervention procedures-are kept consistent between the two groups.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share