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

NCT01622647 | Completed

• 1 other identifier: 2012-Z078-1611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Replacement Surgery

Keywords

NCPAP

Outcome Measures

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.

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

Study Arms (2)

NCPAP Group

ACTIVE COMPARATOR

Group of patients that do receive NCPAP treatment

Other: Nasal Continuous Positive Airway Pressure (NCPAP)

No NCPAP

NO INTERVENTION

subjects will not receive NCPAP

Interventions

Nasal Continuous Positive Airway Pressure (NCPAP) OTHER

Subjects will receive NCPAP

NCPAP Group

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatrix: lead
• New Hanover Regional Medical Center: collaborator
• American Anesthesiology of the Carolinas: collaborator

Study Sites (1)

New Hanover Regional Medical Center

Wilmington, North Carolina, 28406, United States

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Stephen B Smith, MD

  American Anesthesiology of the Carolinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 19, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

US (1)