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Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients with Painless Gastroscopy

N

Nanjing Medical University

Status

Completed

Conditions

Hypoxemia

Treatments

Other: Oxygen delivery mode

Study type

Interventional

Funder types

Other

Identifiers

NCT06139081
KY20230915-10

Details and patient eligibility

About

In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.

Full description

This study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. The control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: Before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. After the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. The incidence of intraoperative hypoxemia was observed.

Enrollment

648 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:

  1. Patients combined with heart or respiratory diseases
  2. Age older than 60
  3. ASA grading II-III
  4. BMI≥30kg/m²,
  5. Snoring or having sleep apnea syndrome
  6. Patients with a STOP-Bang score ≥ 3 (the risk of OSAS is high) are considered to be highly risk of hypoxia.

Exclusion criteria

  1. Severe cardiovascular, pulmonary, liver, or kidney disease
  2. Patients with infections or tumors of airway
  3. History of difficult intubation under general anesthesia
  4. Severe sleep apnea syndrome [hypopnea/apnea hypopnea index (AHI)>40]
  5. Patients allergic to propofol, eggs, soy or egg whites
  6. Pregnancy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

648 participants in 2 patient groups

Group A
Experimental group
Description:
Transnasal oxygen was administered by nasal catheter before gastroscopy, transoral oxygen was administered by nasal catheter during gastroscopy, and transnasal oxygen was administered by nasal catheter after withdrawal of gastroscope.
Treatment:
Other: Oxygen delivery mode
Group B
No Intervention group
Description:
Nasal catheter was used to give oxygen before, during and after withdrawal of gastroscope

Trial contacts and locations

1

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Central trial contact

Shan Tao

Data sourced from clinicaltrials.gov

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