Clinical trial NCT06139081: Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients with Painless Gastroscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose.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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: Five minutes after finishing gastroscopy examination
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Gu Jianping
role: STUDY_CHAIR
References:
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. 2017 Nov 13;47(5):1576-1582. doi: 10.3906/sag-1606-132.
citation: 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/ANE.0000000000005828.
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):101-109. doi: 10.2478/prilozi-2022-0023.