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Clinical Trials/NCT06139081
NCT06139081CompletedNot Applicable

The Effect of Different Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With High Risk of Hypoxia During Painless Gastroscopy

Nanjing First Hospital, Nanjing Medical University1 site in 1 country648 target enrollmentStarted: December 22, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
648
Locations
1
Primary Endpoint
Incidence of hypoxemia

Study Overview

Brief Summary

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.

Detailed 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 After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose.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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:
  • •Patients combined with heart or respiratory diseases
  • •Age older than 60
  • •ASA grading II-III
  • •BMI≥30kg/m²,
  • •Snoring or having sleep apnea syndrome
  • •Patients with a STOP-Bang score ≥ 3 (the risk of OSAS is high) are considered to be highly risk of hypoxia.

Exclusion Criteria

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

Arms & Interventions

Group B

No Intervention

Nasal catheter was used to give oxygen before, during and after withdrawal of gastroscope

Group A

Experimental

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.

Intervention: Oxygen delivery mode (Other)

Outcomes

Primary Outcomes

Incidence of hypoxemia

Time Frame: Five minutes after finishing gastroscopy examination

SpO2\<92%

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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