Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy

Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Preventing Sedation-Related Respiratory Impairment in Adults Undergoing Colonoscopy

The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation associated with the use of intravenous sedation in elective colonoscopy in adult patients.

Inclusion Criteria:

• Male or female subjects undergoing elective colonoscopy at the Study Site who have fewer than three or more than three positive responses on the STOP BANG questionnaire

Exclusion Criteria:

• Presence of severe cardiopulmonary or neurologic disease as determined by the investigator
• History of vascular fragility associated with cutaneous pressure
• History of hypersensitivity to silicone
• Inability to properly fit cNEP collar to the subject
• The presence of excessive facial hair in the region where the cNEP collar is positioned
• Known carotid vascular disease, previous major neck surgery or radiation therapy to the cervical region
• Presence of anatomical abnormalities in the neck or pharyngeal region (such as enlarged tonsils)
• Inability to provide informed consent