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Completed

NCT Number: NCT05783050

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

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

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Key information

Conditions

Supraglottic Airway Obstruction Airway Complication of Anesthesia Airway Obstruction Anesthesia Complication Bronchial Diseases Bronchial Spasm Bronchospasm Epistaxis Hemorrhage Hypoxia Nasal Bleeding Nose Diseases Otorhinolaryngologic Diseases Oxygen Deficiency Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wei Nasal Jet Tube

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

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.

Primary outcomes

  1. Hypoxia incidence

    Time frame: Intra-operative; after device insertion

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

Secondary outcomes

  1. Airway assist maneuver required

    Time frame: Intra-operative; after device insertion

    When the SpO2 value is below 90-92%, airway support maneuvers will be performed

  2. Procedure failure incidence

    Time frame: Intra-operative; after device insertion

    The development of severe hypotension (MAP <55 mmHG), bradycardia ( HR< 45 bpm) and prolonged deep hypoxia(>60 sec SpO2<92%) during procedure

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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