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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139081
• Other study ID #: KY20230915-10
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shan Tao
• Phone: +8618852095135
• Email: 858727933[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: nasal cannula nasal oxygen before gastroscopy placement, nasal cannula oxygen delivery after gastroscopy placement, nasal cannula nasal oxygen delivery after exit gastroscopy, nasal cannula nasal oxygen after exiting gastroscopy. The incidence of intraoperative hypoxemia was observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 662
• Est. completion date: August 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Other:
• Oxygen delivery mode
After the implantation of the mirror, nasal catheter was used to give oxygen through the mouth

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen DX, Yang H, Wu XP, Niu W, Ding L, Zeng HL, Li Q. Comparison of a Nasal Mask and Traditional Nasal Cannula During Intravenous Anesthesia for Gastroscopy Procedures: A Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):615-623. doi: 10.1213/A — View Citation

Gavrilovska-Brzanov A, Shosholcheva M, Kartalov A, Jovanovski-Srceva M, Brzanov N, Kuzamanovska B. Medium-Flow Oxygenation Through Facial Mask and Nasal Cannula in a Limited Resource Setting. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2022 Jul 13;43(2): — View Citation

Tas Z, Hosten T, Kus A, Cesur S, Turkyilmaz N, Arikan A, Solak ZM. Comparison of tidal volume and deep breath preoxygenation techniquesundergoing coronary artery bypass graft surgery: effects of hemodynamicresponse and arterial oxygenation. Turk J Med Sci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoxemia	SpO2<92%	Five minutes after finishing gastroscopy examination