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

NCT ID: NCT06139081

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2024-12-14

Brief Summary

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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

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 After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose.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

Conditions

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Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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.

Group Type EXPERIMENTAL

Oxygen delivery mode

Intervention Type OTHER

After the implantation of the mirror, nasal catheter was used to give oxygen through the mouth

Group B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxygen delivery mode

After the implantation of the mirror, nasal catheter was used to give oxygen through the mouth

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gu Jianping

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29151335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34878412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35843919 (View on PubMed)

Other Identifiers

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KY20230915-10

Identifier Type: -

Identifier Source: org_study_id

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