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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
54
The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck. The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway.
Scripps Green Clinic
La Jolla, California, United States
RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas
Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)
Time frame: 1 hour
The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
Time frame: 1 hour
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Time frame: 1 hour
The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.
interventions such as reduction of sedative medication or jaw thrust.
Time frame: 1 hour
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