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

September 5, 2013 updated by: Pediatrix

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28406
        • New Hanover Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Blood Gas (ABG) test to investigate the breathing effects on patients receiving CPAP treatment during spinal anesthesia for knee replacement.
Time Frame: 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.
ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Collaborators

New Hanover Regional Medical Center
American Anesthesiology of the Carolinas

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-Z078-1611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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