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Completed

NCT Number: NCT03332433

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.

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Key information

Conditions

Hypoxia Adverse Event Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing gastroscope
  • age over 18 years old
  • Signed informed consent form

Exclusion criteria

  • Coagulation disorders or a tendency of nose bleeding;
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
  • Severe aortic stenosis or mitral stenosis;
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
  • Acute myocardial infarction in the last 6 months;
  • Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability;
  • Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
  • Increased intracranial pressure;
  • ASA >III;
  • Mouth, nose, or throat infection;
  • Fever, defined as core body temperature > 37.5oC ;
  • Pregnancy, breastfeeding or positive pregnancy test
  • Emergency procedure

Treatment and study plan

High-flow nasal cannula oxygenation

Device

Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min

Primary outcomes

  1. Incidence of hypoxia

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

    (75% ≤ SpO2 < 90% for <60 s)

Secondary outcomes

  1. Incidence of subclinical respiratory depression

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

    (90% ≤ SpO2 < 95%)

  2. Incidence of severe hypoxia

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

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

  3. Other adverse events

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

    Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Shanghai Pudong New Area People's Hospital
  • Shanghai Tongji Hospital, Tongji University School of Medicine

Registry information

Official study title

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial

Acronym: HONCHO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Sep 5, 2018

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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