Clinical trial NCT05524220: Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction
Official title: Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea, Obesity
Keywords: Obstructive Sleep Apnea
total IV anesthesia
obesity
colonoscopy
Nasal cpap
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Vyaire Medical
First posted: 2022-09-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colonoscopy
* American Society of Anesthesiology (ASA) Physical Status I-III
* BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea

Exclusion Criteria:

* Inpatient status
* Active Congestive Heart Failure Exacerbation
* Untreated ischemic heart disease
* Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
* Emergent procedures
* Pregnancy
* Previous enrollment in this study
* Inability to provide informed consent
* Additional medical testing planned for the same day
* History of allergic reaction to Propofol
* Tracheostomy
* Supra-glottic or sub-glottic tumor
* Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
* Prisoners
* Unable to fit SuperNoVa

Primary outcomes:
measure: Time Taken From Initiation of Induction to the First Airway Intervention
timeFrame: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
Secondary outcomes:
measure: Amount of Propofol Administered During Induction
timeFrame: Within 5 minutes of the start of anesthesia
measure: Total Amount of Propofol Administered During the Procedure
timeFrame: during the procedure (about 45 minutes)
measure: Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
timeFrame: prior to endoscopic intubation,during the procedure
measure: Time Taken From Induction to Endoscopic Insertion
timeFrame: within 10 minutes of start of sedation
measure: Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient
timeFrame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
measure: Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient
timeFrame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
measure: Number of Participants Who Received Airway Maneuvers
timeFrame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
measure: Time Taken for Airway Maneuvers
timeFrame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
measure: Reason for Airway Maneuvers
timeFrame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
measure: Time Taken for the Entire Procedure
timeFrame: from start of procedure to end of procedure (about 45 minutes)
measure: Recovery Time as Assessed by the Time When Subject Was Ready for Discharge
timeFrame: at time of discharge( about one hour from end of procedure)
measure: Recovery Time as Assessed by the Actual Time When Subject Was Discharged
timeFrame: at time of discharge( about one and a half hour from end of procedure)
measure: Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)
timeFrame: at time of discharge(about one hour from end of procedure)
measure: Number of Participants That Tolerated the SuperNO2VA™EtCO2
timeFrame: from start of procedure to end of procedure (about 45 minutes)
measure: Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)
timeFrame: end of procedure (about 45 minutes from start)
measure: Number of Participants That Had Incidences of Cardiac Complications
timeFrame: during the procedure (about 45 minutes)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erikka Washington, MD
role: PRINCIPAL_INVESTIGATOR
References: