Electric Blower Based Ventilator Used During Procedural Sedation

NCT02621463 | Completed Results

• 1 other identifier: IRB_00074281
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Apnea During Procedural Sedation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Noninvasive Ventilation

EXPERIMENTAL

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)

Interventions

Noninvasive Ventilator (V60, Philips) DEVICE

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.

Noninvasive Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Inability/refusal of subject to provide informed consent.
• 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

Sponsors & Collaborators

• University of Utah: lead
• National Aeronautics and Space Administration (NASA): collaborator

Limitations and Caveats

This was not a randomized clinical trial involving multiple facilities. The pharmacodynamic effect of the sedation were unknown. The CPAP machine and the tight-fitting mask may have provided enough of a stimulus as to maintain the patient in a lighter sedation state. The proprietary C-flex and Auto-Trak algorithms are integrated into the V60 ventilator and could not be disabled. The algorithms did cause some variation in pressure levels delivered to the patients.

Results Point of Contact

• Title: Dr. Kai Kuck, PhD
• Organization: University of Utah

kai.kuck@hsc.utah.edu

8012051010

Study Officials

• Kai Kuck, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-04