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

Knee Replacement Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622647
• Other study ID #: 2012-Z078-1611
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: September 5, 2013
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Knee Replacement Surgery

Intervention

Other:
• Nasal Continuous Positive Airway Pressure (NCPAP)
Subjects will receive NCPAP

Locations

Country	Name	City	State
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.	No