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Clinical Trials/NCT05175573
NCT05175573CompletedNot Applicable

Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial

Vyaire Medical1 site in 1 country110 target enrollmentStarted: June 7, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
1
Primary Endpoint
Hypoxemia
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18 years of age or older
  • •Patients undergoing procedural deep sedation
  • •American Society of Anesthesiology (ASA) Physical Status I-III
  • •BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea
  • •Has provided written informed consent
  • •Difficult airway

Exclusion Criteria

  • •Acute exacerbation of respiratory disorders, including COPD and asthma
  • •Emergent procedures
  • •Previous enrollment in this study
  • •Inability to provide informed consent
  • •History of allergic reaction to Propofol
  • •Tracheostomy
  • •Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography

Arms & Interventions

Supplemental Oxygen Face Mask

Active Comparator

Intervention: Supplemental Oxygen Face Mask (Device)

SuperNO2VA Et

Experimental

Continuous positive airway pressure with end-tidal CO2 monitoring

Intervention: SuperNO2VA Et Nasal Positive Pressure Mask (Device)

Outcomes

Primary Outcomes

Hypoxemia

Time Frame: Oxygen saturation below 90% for >15 seconds during procedure

Compare the percentage of time spent with oxygen saturation below 90%.

Secondary Outcomes

  • Oxygen desaturation(Oxygen saturation below 90% for >15 seconds during procedure)
  • Sedation(Total duration of procedure)
  • Airway maneuvers(Total duration of procedure)
  • Procedure Duration(Total duration of procedure)
  • Patient Tolerance(Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No)))
  • Hypoxemic Episodes(Oxygen saturation below 90% for >15 seconds during procedure)
  • Anesthesiologist Satisfaction(Total duration of procedure)
  • Patient Satisfaction(Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent))
  • Surgeon Satisfaction(Total duration of procedure)
  • Cardiac Complications(Total duration of procedure and post procedure in PACU)
  • Procedural Interruptions(Total duration of procedure)
  • Recovery(Total duration of post procedure in PACU)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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