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

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.

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Key information

Conditions

Knee Replacement Surgery

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28406, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Continuous Positive Airway Pressure (NCPAP)

Other

Subjects will receive NCPAP

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

American Anesthesiology of the Carolinas
New Hanover Regional Medical Center

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 19, 2012
Registry last updated: Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed