Incidence of Respiratory Depression in Cesarean Section | NCT01181843

Studies
Incidence of Respiratory Depression in Cesarean Section

NCT01181843

Sponsor

Wake Forest University

Status

Terminated

Last Update Posted

Nov 8, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Respiratory Depression
Postoperative Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression During Postoperative Neuraxial Opioid Analgesia in Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry / Capnography

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

departmental financial support withdrawn

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Aug 12, 2010

First Submission Date that Met QC Criteria

Aug 12, 2010

First Posted Date

Aug 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Name	Class
Forsyth Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to determine the incidence and severity of respiratory depression in elective cesarean section patients who have received a spinal or epidural narcotic called duramorph for management of postoperative pain. A monitoring device called a capnograph as well as a device called a pulse oximeter is placed on the patient once in the recovery room after delivery. The capnograph monitors the carbon dioxide level that the patient breathes out as well as their respiratory rate. The pulse oximeter is a device that is taped on the patient's finger and measures their oxygen saturation level. The monitoring is maintained for 18-24 hours after surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
Cesearean sections receiving duramorph

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RESPIRATORY DEPRESSION	RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT	24 HOURS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are female >= 18 years of age and <=55 years of age with ASA class I-III
Schedule for cesarean surgery
Are willing and able to sign informed consent form for this study
Are willing and able to follow the instruction in this study protocol

Exclusion Criteria:

Have known contraindication/allergy to neuraxial anesthesia or morphine.
Have an ASA class > III
Age > 55 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Pan, MD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Forsyth Medical Center-Dept of OB Anesthesia		Winston-Salem	North Carolina	27103	United States

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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