Airway Obstruction, Apnea, Hypopnea
Conditions
Keywords
colonoscopy, oxygen desaturation
Brief summary
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.
Interventions
DEVICEAirway 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.
Sponsors
5i Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. | 1 hour | interventions such as reduction of sedative medication or jaw thrust. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| no Intervention Routine care is administered without the application of cNEP. | 24 |
| Total | 54 |
Baseline characteristics
| Characteristic | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 18 Participants | 40 Participants |
| Age, Continuous | 60 years | 60 years | 60 years |
| History of sleep apnea | 2 participants | 2 participants | 4 participants |
| Region of Enrollment United States | 30 participants | 24 participants | 54 participants |
| Sex: Female, Male Female | 18 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 24 |
| serious Total, serious adverse events | 0 / 30 | 0 / 24 |
Outcome results
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)
Time frame: 1 hour
Population: Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active cNEP @ -45cmw | 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 | 1.92 RI events |
| no Intervention | 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 | 3.5 RI events |
p-value: <0.022t-test, 2 sided
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active cNEP @ -45cmw | The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. | 1 interventions to restore airway |
| no Intervention | The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. | 0 interventions to restore airway |
Secondary
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Time frame: 1 hour
Secondary
The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
Time frame: 1 hour