Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

28. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1518

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
Tidsramme: Perioperative
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
Perioperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
Tidsramme: Perioperative
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
Perioperative
PETCO₂ monitoring success rate
Tidsramme: Perioperative
proportion of participants from whom a clear, continuous PETCO₂ waveform is obtained
Perioperative
Detection rate of hypoventilation events
Tidsramme: 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
Tidsramme: Perioperative
PETCO₂ > 50 mmHg (or > 45 mmHg) lasting ≥ 30 seconds
Perioperative
Incidence of adverse events
Tidsramme: Perioperative
Record all adverse events that occur during the experiment for final analysis
Perioperative
Airway intervention burden
Tidsramme: Perioperative
jaw thrust/chin lift
Perioperative
Procedural efficiency
Tidsramme: perioperative
Number of withdrawals due to interruption caused by respiratory events
perioperative
Satisfaction: endoscopist satisfaction and patient satisfaction.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qianfoshan Hospital

Efterforskere

  • Ledende efterforsker: Jianbo Wu, Doctoral, Shandong First Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YXLL-KY-2026(086)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Luftvejsstyring

Kliniske forsøg med Novel Multifunctional Oropharyngeal Airway

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner