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Completed

NCT Number: NCT01895062

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

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Key information

Conditions

Airway Obstruction Apnea Hypopnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scripps Green Clinic

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Airway Management System (AMS)

Device

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.

Primary outcomes

  1. 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

    Time frame: 1 hour

    Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)

Secondary outcomes

  1. The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.

    Time frame: 1 hour

  2. The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.

    Time frame: 1 hour

  3. The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.

    Time frame: 1 hour

    interventions such as reduction of sedative medication or jaw thrust.

Sponsors and collaborators

Lead sponsor

5i Sciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Aug 6, 2014

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.

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