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

28 mei 2026 bijgewerkt door: Qianfoshan Hospital

Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Study Title Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled Trial

Principal Investigator Dr. Wu Jianbo, Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Participating Centers A total of 29 centers across China (including Zhejiang University First Affiliated Hospital, Hebei Medical University Second Hospital, Qilu Hospital of Shandong University, etc.)

Study Objective To evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia compared to conventional nasal cannula with standard mouthpiece in patients undergoing sedated gastrointestinal endoscopy.

Study Design Multicenter, prospective, parallel-group, randomized controlled trial.

Sample Size 1,518 patients (759 per group), accounting for a 20% dropout rate. Power: 90%, two-sided alpha: 0.05.

Participant Criteria

Inclusion: Age 18-80 years; ASA I-II; scheduled for elective sedated gastroscopy + colonoscopy; written informed consent.

Exclusion: Known respiratory disease (asthma, COPD, moderate-severe OSA, etc.); bleeding tendency or oral/nasal mucosal injury; severe cardiac/renal/hepatic dysfunction; therapeutic endoscopy (e.g., polypectomy, EMR); pregnancy; known drug allergy; emergency procedure; alcohol abuse; psychiatric illness; myasthenia gravis; participation in another trial within 3 months; refusal.

Interventions

Experimental group (MOPA): After standard sedation (fentanyl 0.05 μg/kg + propofol 1.5-2.5 mg/kg, then propofol infusion 4-12 mg/kg/h), a novel multifunctional oropharyngeal airway (integrating a bite block, oropharyngeal airway, oxygen delivery channel, and CO₂ sampling port) is inserted. Oxygen 3-4 L/min is delivered via the device, and PETCO₂ is continuously monitored through the sampling port.

Control group (conventional mouthpiece): Same sedation regimen. Patients receive oxygen 3-4 L/min via nasal cannula. PETCO₂ is monitored via nasal cannula sampling line. No oropharyngeal airway is used.

Both groups receive standardized rescue interventions for hypoxemia or ventilatory abnormalities.

Primary Endpoint Incidence of hypoxemia defined as 75% ≤ SpO₂ < 90% lasting < 60 seconds during the procedure.

Secondary Endpoints

Severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 s)

PETCO₂ monitoring success rate (proportion with clear continuous waveform)

Detection rate of hypoventilation events (apnea ≥15-20 s; respiratory rate <8/min for ≥30 s) and early warning time before SpO₂ decline

Incidence of hypercapnia (PETCO₂ >50 mmHg or >45 mmHg for ≥30 s)

Adverse events: airway injury, regurgitation, aspiration, coughing, laryngospasm, post-procedural sore throat, hoarseness, dental/oral soft tissue injury

Airway intervention burden (jaw thrust, increased O₂ flow, procedure pause, face-mask ventilation, laryngeal mask/intubation)

Procedural efficiency (scope insertion-to-withdrawal time, number of interruptions/withdrawals due to respiratory events)

Endoscopist satisfaction (0-10 scale) and patient satisfaction (customized 0-2 per item score)

Safety Outcomes Device-related (mucosal injury, bleeding, sore throat), respiratory events (cough, laryngospasm, aspiration, need for advanced airway), systemic complications (hemodynamic instability, unplanned hospitalization/ICU), serious adverse events (refractory hypoxemia, emergency airway support, arrhythmia, myocardial ischemia, anaphylaxis, stroke).

Statistical Analysis Primary endpoint comparison using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test as appropriate. All tests two-sided, significance level α=0.05. Analysis sets: FAS, PP, SS. Missing data handled by multiple imputation where applicable.

Randomization and Blinding Centralized randomization via EDC system using stratified block randomization (block sizes 4,6,8; stratified by center). Patients are blinded to group assignment. Operators are unblinded due to device appearance. Outcome assessors and statisticians are blinded until database lock (two-stage unblinding).

Study Duration Start anticipated June 2026, completion December 2027.

Expected Publications 1-2 SCI-indexed papers reporting the primary and secondary outcomes.

Studietype

Ingrijpend

Inschrijving (Geschat)

1518

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental group: Novel multifunctional oropharyngeal airway group
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.
Apparaat: Novel Multifunctional Oropharyngeal Airway
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.
Geen tussenkomst: Control group: Conventional mouthpiece group
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
Tijdsspanne: Perioperative
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
Perioperative

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
Tijdsspanne: Perioperative
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
Perioperative
PETCO₂ monitoring success rate
Tijdsspanne: Perioperative
proportion of participants from whom a clear, continuous PETCO₂ waveform is obtained
Perioperative
Detection rate of hypoventilation events
Tijdsspanne: Perioperative
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)
Perioperative
Incidence of hypercapnia
Tijdsspanne: Perioperative
PETCO₂ > 50 mmHg (or > 45 mmHg) lasting ≥ 30 seconds
Perioperative
Incidence of adverse events
Tijdsspanne: Perioperative
Record all adverse events that occur during the experiment for final analysis
Perioperative
Airway intervention burden
Tijdsspanne: Perioperative
jaw thrust/chin lift
Perioperative
Procedural efficiency
Tijdsspanne: perioperative
Number of withdrawals due to interruption caused by respiratory events
perioperative
Satisfaction: endoscopist satisfaction and patient satisfaction.
Tijdsspanne: perioperative
Note - Patient satisfaction: Each participant, in the absence of research personnel, will provide quantitative scores on predefined dimensions (pain level, foreign body sensation, comfort, quality of recovery, and overall experience). Each item is scored from 0 to 2 points, and the sum of the scores on all items will be used as the final satisfaction assessment. Endoscopist satisfaction: This is assessed using a 0-10 point scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied". Based on their actual experience during the procedure, the endoscopist will select the corresponding number on the rating scale to indicate their satisfaction with the participant's cooperation and response throughout the entire procedure.
perioperative

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Qianfoshan Hospital

Onderzoekers

  • Hoofdonderzoeker: Jianbo Wu, Doctoral, Shandong First medical university

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

7 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • YXLL-KY-2026(086)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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