NCT05783050

Brief Summary

Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

March 13, 2023

Last Update Submit

August 9, 2024

Conditions

Supraglottic Airway ObstructionAirway Complication of AnesthesiaAirway ObstructionAnesthesia ComplicationBronchospasmNasal BleedingOxygen Deficiency

Keywords

Wei Nasal Jet TubeAirway ComplicationNasal Cannula Oxygen SupportGastrointestinal Endoscopysedation

Outcome Measures

Primary Outcomes (1)

  • Hypoxia incidence

    Hypoxia is defined as SpO2 \<92% at any time.

    Intra-operative; after device insertion

Secondary Outcomes (2)

  • Airway assist maneuver required

    Intra-operative; after device insertion

  • Procedure failure incidence

    Intra-operative; after device insertion

Study Arms (2)

Wei Nasal Jet Tube Group (Group W)

ACTIVE COMPARATOR

After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.

Device: Wei Nasal Jet Tube

Nasal Cannula Oxygen Support Group (Group N)

ACTIVE COMPARATOR

After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.

Device: Nasal Cannula Oxygen Support

Interventions

Wei Nasal Jet TubeDEVICE

The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.

Wei Nasal Jet Tube Group (Group W)
Nasal Cannula Oxygen SupportDEVICE

The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.

Nasal Cannula Oxygen Support Group (Group N)

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing gastrointestinal endoscopy
  • ASA Physical Status 1-2
  • Body mass index 18.5 - 35 kg/m2

You may not qualify if:

  • High risk of pulmonary aspiration
  • Pregnancy
  • Anesthesic drug allergies
  • Difficult airway or facial deformities
  • Height \<155 cm
  • Alcohol or narcotic drug usage
  • Restrictive or obstructive pulmonary diseases
  • Hepatic cardiac or renal failure
  • Neurologic or cognitive deficiencies.
  • Previous cervical surgery or cervical radiotherapy
  • Previous esophagus surgery
  • Psychotic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Airway ObstructionBronchial SpasmEpistaxisHypoxia

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesBronchial DiseasesNose DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • ISMAIL SUMER, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
computer-assisted randomization method
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 30, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

TU(1)