NCT06139081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
648

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

January 14, 2025

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

October 26, 2023

Last Update Submit

January 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoxemia

    SpO2\<92%

    Five minutes after finishing gastroscopy examination

Study Arms (2)

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.

Other: Oxygen delivery mode

Group B

NO INTERVENTION

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

Interventions

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

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (3)

  • 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.

    PMID: 29151335BACKGROUND
  • 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.

    PMID: 34878412BACKGROUND
  • 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.

    PMID: 35843919BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gu Jianping

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 18, 2023

Study Start

September 22, 2023

Primary Completion

December 13, 2024

Study Completion

December 14, 2024

Last Updated

January 14, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations