Knee Replacement SurgeryNCT01622647
The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia
A study testing Nasal Continuous Positive Airway Pressure (NCPAP) in people with Knee Replacement Surgery, run by Pediatrix at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Knee Replacement Surgery
- What is being tested?
- Nasal Continuous Positive Airway Pressure (NCPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic narcotic or benzodiazepine treatment or dependency
- Allergy to Midazolam, Fentanyl, or Propofol
- Severe upper respiratory infection within the past three weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
New Hanover Regional Medical Center
Wilmington, North Carolina, 28406
About this study
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
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
- Being tested
- Nasal Continuous Positive Airway Pressure (NCPAP)
- Keywords
- NCPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Continuous Positive Airway Pressure (NCPAP)Other
Subjects will receive NCPAP
| Study group | Role | What they receive |
|---|---|---|
| NCPAP Group | Active comparator | Group of patients that do receive NCPAP treatment Receives: Other: Nasal Continuous Positive Airway Pressure (NCPAP) |
| No NCPAP | No intervention | subjects will not receive NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- New Hanover Regional Medical Center, American Anesthesiology of the Carolinas
- Responsible party
- Sponsor
- Investigators
- Stephen B Smith, MD, Principal investigator, American Anesthesiology of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622647
- Sponsor's protocol ID
- 2012-Z078-1611
- Status last verified
- Sep 2013
- First submitted
- 5 Jun 2012
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01622647
- Acronym / sponsor ID
- 2012-Z078-1611
- Conditions
- Knee Replacement Surgery
- Keywords
- NCPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- New Hanover Regional Medical Center, American Anesthesiology of the Carolinas
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCPAP Group | Active comparator | Other: Nasal Continuous Positive Airway Pressure (NCPAP)Group of patients that do receive NCPAP treatment |
| No NCPAP | No intervention | –subjects will not receive NCPAP |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Continuous Positive Airway Pressure (NCPAP)Subjects will receive NCPAP | Other | NCPAP Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B Smith, MD principal investigator
American Anesthesiology of the Carolinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Continuous Positive Airway Pressure (NCPAP) in people with Knee Replacement Surgery, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.