The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia

Sponsor

Mednax Center for Research, Education, Quality and Safety (Other)

Overall Status

Completed

CT.gov ID

NCT01622647

Collaborator

New Hanover Regional Medical Center (Other), American Anesthesiology of the Carolinas (Other)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed study intends to investigate several aspects of the respiratory effects of intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery. The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is expected to be elevated as a result of intravenous sedation and postural factors. Further, the study will investigate how application of Nasal Continuous Positive Airway Pressure (N-CPAP) may impact PaCO2.

Condition or Disease	Intervention/Treatment	Phase
Knee Replacement Surgery	Other: Nasal Continuous Positive Airway Pressure (NCPAP)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia With Intravenous Sedation for Total Knee Arthroplasty

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NCPAP Group Group of patients that do receive NCPAP treatment	Other: Nasal Continuous Positive Airway Pressure (NCPAP) Subjects will receive NCPAP
No Intervention: No NCPAP subjects will not receive NCPAP

Arm

Intervention/Treatment

Active Comparator: NCPAP Group

Group of patients that do receive NCPAP treatment

Other: Nasal Continuous Positive Airway Pressure (NCPAP)

Subjects will receive NCPAP

No Intervention: No NCPAP

subjects will not receive NCPAP

Outcome Measures

Primary Outcome Measures

Arterial Blood Gas (ABG) test to investigate the breathing effects on patients receiving CPAP treatment during spinal anesthesia for knee replacement. [ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.]
The TEST patients will receive CPAP treatment immediately after the first ABG specimen is drawn. After collection of the second ABG specimen, the anesthesia team may elect to remove the N-CPAP mask or maintain it as deemed best. The CONTROL patients will not receive CPAP treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiology Class I, II, or III patients
Age over 21 years and under 70 years
Planned surgical procedure is total knee arthroplasty (TKA) to be performed at Cape Fear Hospital
Body Mass Index less than 40
The patient and their attending anesthesiologist select spinal anesthesia with intravenous sedation, intrathecal morphine, and femoral nerve block as the preferred anesthesia plan

Exclusion Criteria:

Prior diagnosis of Obstructive Sleep Apnea based upon sleep study
History of Stroke with residual neurologic deficit
Prior diagnosis of Emphysema, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, or Asthma, or other chronic lung disease
Recent history of significant nasal obstruction, epistaxis, or facial abnormality that may interfere with proper fit of a nasal CPAP mask
Pregnancy
Mental or other disability preventing a patient from personally giving informed consent
Chronic narcotic or benzodiazepine treatment or dependency
Allergy to Midazolam, Fentanyl, or Propofol
Severe upper respiratory infection within the past three weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28406

Sponsors and Collaborators

Mednax Center for Research, Education, Quality and Safety
New Hanover Regional Medical Center
American Anesthesiology of the Carolinas

Investigators

Principal Investigator: Stephen B Smith, MD, American Anesthesiology of the Carolinas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mednax Center for Research, Education, Quality and Safety

ClinicalTrials.gov Identifier:

NCT01622647

Other Study ID Numbers:

2012-Z078-1611

First Posted:

Jun 19, 2012

Last Update Posted:

Sep 6, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Mednax Center for Research, Education, Quality and Safety

NCPAP

Study Results

No Results Posted as of Sep 6, 2013