Electric Blower Based Ventilator Used During Procedural Sedation

Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.

Study Overview

• Status: Completed
• Conditions: Apnea During Procedural Sedation
• Intervention / Treatment: Device: Noninvasive Ventilator (V60, Philips)

Detailed Description

All study procedures will be performed in adult patients following informed consent at the endoscopy suite of the University of Utah Health Sciences Center in Salt Lake City, Utah. A ventilation mask will be placed on the patient's face and connected to the ventilator. Supplemental oxygen will be delivered by the ventilator through the mask; the concentration of oxygen delivered will be left to the clinician's discretion. A modified mask with multiple small leaks will be used with a standard elastomeric H-strap to secure it to the patient's face.

The endoscopy suite nurse and technicians will attach all clinically necessary standard sensors and connect them to the patient and monitoring system. Height, weight, and neck circumference will be measured and recorded digitally on an encrypted laptop. In addition to the standard of care monitors, the investigators will collect data from additional non-invasive modalities and save the data to a laptop using custom software for later analysis.

Pressure and flow sensors included in the ventilator will be used to monitor the patients' tidal volumes and respiratory rate during the procedure. The data that will be collected and recorded on the laptop will include: RIP data, mask pressure, flow, and breath rate. An additional flow sensor will be placed in line with the ventilator.

The objective of this study is threefold: Demonstrate in patients undergoing procedural sedation (e.g., for colonoscopy) that obstructive apnea can successfully be avoided by stenting the airway open using CPAP, demonstrate that we can successfully detect periods of zero ventilation, and demonstrate the functionality of the modified standard mask.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 18 years of age
• undergoing a colonoscopy procedure
• receiving registered nurse-administered procedural sedation at the University of Utah Health Sciences Center
• agree to participate
• written informed consent

Exclusion Criteria:

• Inability/refusal of subject to provide informed consent.
• Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.
• Pregnant patients and patients with an ASA (American Society of Anesthesiology) physical status of IV or V.
• Patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study.
• Patients with a BMI > 35 will not be included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noninvasive Ventilation; Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator.	Device: Noninvasive Ventilator (V60, Philips); The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time the Patient Will Experience Apnea	Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %)	Duration of Diagnostic Procedure (Colonoscopy)

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Aeronautics and Space Administration (NASA)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00074281