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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active cNEP @ -45cmw | Experimental | cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. |
|
| no intervention | No Intervention | Routine care is administered without the application of cNEP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| The Safety of cNEP as Determined by Adverse Events Reported by the Investigators. | 1 hour | |
| The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group. | 1 hour | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Coyle, M.D. | Scripps Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Clinic | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27110692 | Derived | Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active cNEP @ -45cmw | cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. Airway Management System (AMS): 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. |
| FG001 | no Intervention | Routine care is administered without the application of cNEP. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants in the cNEP group was estimated from the number required to show a 50% decrease in the primary endpoint compared to the no intervention group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active cNEP @ -45cmw | cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. Airway Management System (AMS): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several. | Posted | Mean | 95% Confidence Interval | RI events | 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active cNEP @ -45cmw | cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. Airway Management System (AMS): 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Rose | 5i Sciences | 858-759-2205 | rrose@5isciences.com |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| 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. |
| 1 hour |
| BG001 | no Intervention | Routine care is administered without the application of cNEP. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of sleep apnea | history of sleep apnea as reported by the study participant | Number | participants |
|
| OG001 | no Intervention | Routine care is administered without the application of cNEP. |
|
|
|
| Secondary | The Safety of cNEP as Determined by Adverse Events Reported by the Investigators. | Not Posted | 1 hour |
| Secondary | The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group. | Not Posted | 1 hour |
| Secondary | 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. | Posted | Number | interventions to restore airway | 1 hour |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | no Intervention | Routine care is administered without the application of cNEP. | 0 | 24 | 0 | 24 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |