Clinical trial · Interventional
Nasal Mask Kit in Gastrointestinal Endoscopy
Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
NCT05405530CI-TRIAL-00090613NASOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyp | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Polyp | — | UNRESOLVED | — |
| Hypoxia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nasal mask oxygen kit | Device | — | UNRESOLVED |
| regular nasal cannula | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nasal mask oxygen group
- description
- In this group, patients use the nasal mask oxygen kit for oxygenation.
- interventionNames
- Device: nasal mask oxygen kit
- type
- ACTIVE_COMPARATOR
- label
- regular nasal cannula group
- description
- In this group, patients use the regular nasal cannula for oxygenation.
- interventionNames
- Device: regular nasal cannula
Primary outcomes (1)
- measure
- The incidence of hypoxia
- timeFrame
- Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 18≤ Age ≤60 * patients undergoing combined gastroendoscopy and colonoscopy procedure * patients signed informed consent form * ASA classification I-II * Estimated procedure time \<=45min Exclusion Criteria: * Coagulation disorders or a tendency of nose bleeding * Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) * Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy) * hypoxia (SpO2\< 90 % ) * Upper respiratory tract infection * increased intracranial pressure * Fever (core body temperature \>37.5 ℃) * Pregnancy, breastfeeding, or positive pregnancy test * Emergency procedure or surgery * Multiple trauma * Allergy to propofol or tape and adhesives * BMI\<18.5 or BMI\>30
References
Publications (1)
- DERIVEDCheng X, Zhang X, Zhang J, Hu Z, Zhang J, Lian Q, Ding X, He Y, Shi M, Zhang Y, Tian M, Zheng H, Li Z, Wang Y, Yu W, Shao J, Su D. Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial. BMJ Open Gastroenterol. 2025 Jul 7;12(1):e001834. doi: 10.1136/bmjgast-2025-001834. PMID 40623715