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Completed

NCT Number: NCT05405530

Nasal Mask Kit in Gastrointestinal Endoscopy

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.

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Key information

Conditions

Hypoxia Colon Cancer Colon Polyp Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastric Polyp Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyposis, Gastric Polyps Signs and Symptoms Signs and Symptoms, Respiratory Stomach Diseases Stomach Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital, Zhengzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal mask oxygen kit

Device

Using the nasal mask oxygen kit for oxygenation.

Regular Nasal Cannula

Device

Using nasal cannula for oxygenation.

Primary outcomes

  1. The incidence of hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

    (75% ≤ SpO2 < 90% for <60 s)

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

    (90% ≤ SpO2 < 95%)

  2. The incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    (SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s)

  3. The incidence of other adverse events

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • First Affiliated Hospital of Kunming Medical University
  • Henan Provincial People's Hospital

Registry information

Official study title

Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial

Acronym: NASO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2022
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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