Airway ObstructionPhase 1/2NCT01895062

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

A Phase 1/2 study testing Airway Management System (AMS) in people with Airway Obstruction and Apnea, run by 5i Sciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Airway Obstruction, Apnea, Hypopnea
What is being tested?: Airway Management System (AMS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Mar 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Scripps Green Clinic
La Jolla, California, 92037

Other trials in United States

About this study

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

Conditions: Airway Obstruction, Apnea, Hypopnea
Being tested: Airway Management System (AMS)
Keywords: colonoscopy, oxygen desaturation
Medical subject headings: Airway Obstruction, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01895062
Study group	Role	What they receive
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. Receives: Device: Airway Management System (AMS)
no intervention	No intervention	Routine care is administered without the application of cNEP.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 1 hour

Secondary outcomes (3)

The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
Measured: 1 hour
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Measured: 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.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Mar 2014

First posted10 Jul 2013 (estimated)
Study startMar 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Airway ObstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01895062
Sponsor's protocol ID: 5iS-009
Status last verified: Jul 2014
First submitted: 29 Mar 2013
Last updated: 6 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27110692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Preventing Sedation-Related Respiratory Impairment in Adults Undergoing Colonoscopy
ClinicalTrials.gov ID: NCT01895062
Acronym / sponsor ID: 5iS-009
Conditions: Airway Obstruction, Apnea, Hypopnea
Keywords: colonoscopy, oxygen desaturation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: 5i Sciences, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 10 Jul 2013 (estimated)
Results: Posted 6 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
active cNEP @ -45cmw	Experimental	Device: Airway Management System (AMS)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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	active cNEP @ -45cmw

Primary outcome

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)

3 secondary outcomes

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.
Time frame: 1 hour

Results and safety

Results posted to the registry on 6 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active cNEP @ -45cmw	30	30
no Intervention	24	24

Primary outcome: 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 (95% Confidence Interval). Unit: RI events

Measure	Active cNEP @ -45cmw n = 29	no Intervention n = 24
Value	1.92 (1.1 to 2.75)	3.5 (2.37 to 4.64)

Active cNEP @ -45cmw vs no Intervention: p <0.022, t-test, 2 sided

Population analysed: Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active cNEP @ -45cmw	0 of 30 (0%)	0 of 30 (0%)	Not reported
no Intervention	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27110692Kais 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walter Coyle, M.D. principal investigator

Scripps Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Airway Management System (AMS) in people with Airway Obstruction and Apnea, run by 5i Sciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01895062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.