Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients

NCT ID: NCT05783050

Last Updated: 2024-08-12

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-07-01

Brief Summary

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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

Detailed Description

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Gastrointestinal endoscopy is performed as standard for the diagnosis of many gastrointestinal diseases. During gastrointestinal endoscopy, sedoanalgesia is applied to relieve patients' pain and increase patient comfort. Anesthetic drugs used for sedoanalgesia may cause respiratory depression and hypoxia in patients. Hypoxia resulting from hypoventilation in patients is responsible for many events, including coronary ischemia. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia. 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. Our study will show us which method is more beneficial in preventing hypoxia and other side effects, providing comfort for the doctor performing the procedure and for the patient undergoing the procedure. 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

Conditions

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Supraglottic Airway Obstruction Airway Complication of Anesthesia Airway Obstruction Anesthesia Complication Bronchospasm Nasal Bleeding Oxygen Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
computer-assisted randomization method

Study Groups

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Wei Nasal Jet Tube Group (Group W)

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

Group Type ACTIVE_COMPARATOR

Wei Nasal Jet Tube

Intervention Type DEVICE

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)

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

Group Type ACTIVE_COMPARATOR

Nasal Cannula Oxygen Support

Intervention Type DEVICE

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.

Interventions

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Wei Nasal Jet Tube

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.

Intervention Type DEVICE

Nasal Cannula Oxygen Support

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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İsmail SÜMER

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ISMAIL SUMER, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ismail04

Identifier Type: -

Identifier Source: org_study_id

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