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CompletedNCT01622647Updated Sep 6, 2013

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

An interventional study of Nasal Continuous Positive Airway Pressure (NCPAP) in Knee Replacement Surgery, sponsored by Pediatrix. Completed at 1 site in United States. Open to participants aged 21 Years to 69 Years. Per ClinicalTrials.gov, last updated 2013-09-06.

Sponsored by Pediatrix · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Replacement Surgery

Keywords

  • NCPAP
03

In context

Lead sponsor

Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    NCPAP Group

    Group of patients that do receive NCPAP treatment

    Other: Nasal Continuous Positive Airway Pressure (NCPAP)

  • No intervention
    No NCPAP

    subjects will not receive NCPAP

Interventions

  • OtherNasal Continuous Positive Airway Pressure (NCPAP)

    Subjects will receive NCPAP

06

What researchers measure

Primary outcomes

  1. Arterial Blood Gas (ABG) test to investigate the breathing effects on patients receiving CPAP treatment during spinal anesthesia for knee replacement.

    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.

    Time frame: ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.

07

Study locations

1 site
  • New Hanover Regional Medical Center
    Wilmington, North Carolina 28406, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01622647
Lead sponsor
Pediatrix
Collaborators
New Hanover Regional Medical Center, American Anesthesiology of the Carolinas
Responsible party
Sponsor
First posted
Jun 19, 2012
Start date
Jul 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Sep 6, 2013

Study contacts

Stephen B Smith, MD
principal investigator · American Anesthesiology of the Carolinas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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