Clinical trial NCT02621463: Electric Blower Based Ventilator Used During Procedural Sedation
Official title: Electric Blower Based Ventilator Used During Procedural Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea During Procedural Sedation
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Aeronautics and Space Administration (NASA)
First posted: 2015-12-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Time the Patient Will Experience Apnea
timeFrame: Duration of Diagnostic Procedure (Colonoscopy)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Kai Kuck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: