Bariatric SurgeryNCT01896206

CNAP Accuracy in the Bariatric Surgery Population

A study testing CNAP monitor in people with Bariatric Surgery, run by Joseph D. Tobias at 1 site in United States.

Completed

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

Trial summary

This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood… Read more about this study

Who is it for?: Any age
Conditions the study is for: Bariatric Surgery
What is being tested?: CNAP monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Dec 2013
Phase: Interventional
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Who cannot join

Patients with history of a peripheral neurologic or neuropathic disorder
Patients in whom an invasive arterial cannula cannot be placed
Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
Edematous patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Conditions: Bariatric Surgery
Being tested: CNAP monitor

What participants receive

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

CNAP monitorDevice
Patients undergoing bariatric surgery and being monitored using the CNAP monitor.

Study groups in NCT01896206
Study group	Role	What they receive
CNAP monitor	Experimental	Subjects undergoing bariatric surgery and monitored using the CNAP monitor. Receives: Device: CNAP monitor

What is being measured

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

The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.
To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.
Measured: Participants will be followed for the duration of surgery, an expected average of 2 hours.

Timeline

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

Jun 2013Dec 2013

First posted11 Jul 2013 (estimated)
Study startJun 2013
Primary completionDec 2013
Study completionDec 2013

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.
Other trials for Bariatric SurgeryStudies 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01896206
Sponsor's protocol ID: IRB12-00808
Status last verified: Feb 2015
First submitted: 27 Jun 2013
Last updated: 27 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Bariatric Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CNAP Accuracy in the Bariatric Surgery Population
ClinicalTrials.gov ID: NCT01896206
Acronym / sponsor ID: IRB12-00808
Conditions: Bariatric Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Joseph D. TobiasUniversity, hospital or other
Study start: Jun 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 11 Jul 2013 (estimated)
Results: Posted 27 Feb 2015

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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CNAP monitor	Experimental	Device: CNAP monitorSubjects undergoing bariatric surgery and monitored using the CNAP monitor.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Key exclusion criteria (4 listed)

Patients with history of a peripheral neurologic or neuropathic disorder
Patients in whom an invasive arterial cannula cannot be placed
Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
Edematous patients

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
CNAP monitorPatients undergoing bariatric surgery and being monitored using the CNAP monitor.	Device	CNAP monitor

Primary outcome

The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.
Time frame: Participants will be followed for the duration of surgery, an expected average of 2 hours.
To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.

Results and safety

Results posted to the registry on 27 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CNAP Monitor	21	21

Primary outcome: The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.

Time frame: Participants will be followed for the duration of surgery, an expected average of 2 hours.. Mean (Standard Deviation). Unit: mmHg

Measure	CNAP Monitor n = 18
Value	7.7 (4.9)

Population analysed: The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CNAP Monitor	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bariatric Surgery

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Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
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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.

Joseph D Tobias, MD principal investigator

Nationwide Children's Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing CNAP monitor in people with Bariatric Surgery, run by Joseph D. Tobias 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 2 inclusion and 4 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 27 Feb 2015. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2015). 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?

The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. (time frame: Participants will be followed for the duration of surgery, an expected average of 2 hours.). 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 NCT01896206.

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 27 Feb 2015.