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

Not Applicable

Completed

• Conditions: Knee Replacement Surgery
• Interventions: Other: Nasal Continuous Positive Airway Pressure (NCPAP)

• Registration Number: NCT01622647
• Lead Sponsor: Pediatrix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Study Start: 2012-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCPAP Group	Nasal Continuous Positive Airway Pressure (NCPAP)	Group of patients that do receive NCPAP treatment

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New Hanover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States