An interventional study of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support in Supraglottic Airway Obstruction, Airway Complication of Anesthesia and Airway Obstruction, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Prevention
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
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
147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.
This study's enrollment of 100 is above the median of 53 across 92 interventional studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
High risk of pulmonary aspiration
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Device: Wei Nasal Jet Tube
After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.
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.
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.
Hypoxia incidence
Hypoxia is defined as SpO2 \<92% at any time.
Time frame: Intra-operative; after device insertion
Airway assist maneuver required
When the SpO2 value is below 90-92%, airway support maneuvers will be performed
Time frame: Intra-operative; after device insertion
Procedure failure incidence
The development of severe hypotension (MAP \<55 mmHG), bradycardia ( HR\< 45 bpm) and prolonged deep hypoxia(\>60 sec SpO2\<92%) during procedure
Time frame: Intra-operative; after device insertion
Ran from Mar 2023 to primary completion in Jun 2023, 2 months.
Of 36 non-industry interventional studies with no phase under Airway Obstruction, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 37. This study's 2 months is below that.
Counting every sponsor, half of 44 studies reached it within 16 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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