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

Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05783050
Enrollment
100
Registered
2023-03-24
Start date
2023-03-30
Completion date
2023-07-01
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation

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

Detailed description

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

Interventions

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.

DEVICENasal 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.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

computer-assisted randomization method

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoxia incidenceIntra-operative; after device insertionHypoxia is defined as SpO2 \<92% at any time.

Secondary

MeasureTime frameDescription
Airway assist maneuver requiredIntra-operative; after device insertionWhen the SpO2 value is below 90-92%, airway support maneuvers will be performed
Procedure failure incidenceIntra-operative; after device insertionThe development of severe hypotension (MAP \<55 mmHG), bradycardia ( HR\< 45 bpm) and prolonged deep hypoxia(\>60 sec SpO2\<92%) during procedure

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026