Respiratory DepressionNCT03151226

OSA Screen Negative With Spinal Duramorph

A study testing Capnography monitoring in people with Respiratory Depression, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Respiratory Depression
What is being tested?: Capnography monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2015to 1 Oct 2015
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 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

OSA screen negative per hospital protocol
age 18 or greater
BMI>35
consent to participate to wear capnography and pulse oximetry monitoring devices post delivery

Who cannot join

Spanish speaking only
under age 18
contraindication to receiving drugs utilized in delivery anesthetic

Trial locations and contacts

1 site in 1 country.

United States1 site

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography

Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.

Conditions: Respiratory Depression
Being tested: Capnography monitoring
Keywords: obstructive sleep apnea screen negative, respiratory depression, cesarean section
Medical subject headings: Respiratory Insufficiency

What participants receive

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

Capnography monitoringDevice
Also called pulse oximetry
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery

Study groups in NCT03151226
Study group	Role	What they receive
capnography monitoring	Other	single arm, all subjects receiving duramorph will receive capnography monitoring Receives: Device: Capnography monitoring

What is being measured

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

Respiratory Depression/Suppression
defined by values obtained utilizing capnography and pulse oximetry
Measured: up to 24 hours

Timeline

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

3 Aug 20151 Oct 2015

First posted12 May 2017
Study start3 Aug 2015
Primary completion1 Oct 2015
Study completion1 Oct 2015

Why it stopped: Technical difficulty and feasibility issues

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 Respiratory DepressionStudies 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03151226
Sponsor's protocol ID: IRB00033095
Status last verified: Aug 2018
First submitted: 31 Aug 2015
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: 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

RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
Not yet recruiting
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
Not yet recruitingObservational study
Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea, Postoperative Analgesia
Active, not recruitingPhase 2/3
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain
Pain, Respiratory Depression

All Respiratory Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography
ClinicalTrials.gov ID: NCT03151226
Acronym / sponsor ID: IRB00033095
Conditions: Respiratory Depression
Keywords: obstructive sleep apnea screen negative, respiratory depression, cesarean section
Study type: Interventional
Recruitment status: TerminatedReason stopped: Technical difficulty and feasibility issues
Enrolment: 3 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 3 Aug 2015 (actual)
Primary completion: 1 Oct 2015 (actual)
Study completion: 1 Oct 2015 (actual)
First posted: 12 May 2017 (actual)
Results: Posted 8 Mar 2018

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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
capnography monitoring	Other	Device: Capnography monitoringsingle arm, all subjects receiving duramorph will receive capnography monitoring

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

OSA screen negative per hospital protocol
age 18 or greater
BMI>35
consent to participate to wear capnography and pulse oximetry monitoring devices post delivery

Key exclusion criteria (3 listed)

Spanish speaking only
under age 18
contraindication to receiving drugs utilized in delivery anesthetic

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
Capnography monitoringAlso: pulse oximetrycapnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery	Device	capnography monitoring

Primary outcome

Respiratory Depression/Suppression
Time frame: up to 24 hours
defined by values obtained utilizing capnography and pulse oximetry

Results and safety

Results posted to the registry on 8 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Capnography Monitoring	3	0

Primary outcome: Respiratory Depression/Suppression

Time frame: up to 24 hours

Population analysed: the 2 subjects who wore device did not wear the device enough to be evaluable data

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capnography Monitoring	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Depression

RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
Not yet recruiting
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
Not yet recruitingObservational study
Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea, Postoperative Analgesia
Active, not recruitingPhase 2/3
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain
Pain, Respiratory Depression

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.

Peter H Pan, MD principal investigator

Wake Forest University Health Sciences

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

Questions about this trial

What is this clinical trial studying?

A study testing Capnography monitoring in people with Respiratory Depression, run by Wake Forest University Health Sciences 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Sep 2018. 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 8 Mar 2018). 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?

Respiratory Depression/Suppression (time frame: up to 24 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 NCT03151226.

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 7 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.