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OpenTrials
Completed

NCT Number: NCT02621463

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Time the Patient Will Experience Apnea

    Time frame: Duration of Diagnostic Procedure (Colonoscopy)

    Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2015
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.