AnesthesiaNCT02652117
Regional Anesthesia in Cardiac Pediatric Patients Less Than 5 Years Old
An observational study of Anesthesia, run by University of Iowa.
Trial summary
This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia. Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 545 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jul 2013
- Phase
- Observational
- 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 Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cardiac Pediatric Patients less than 5 years old
Who may be able to join
- Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013
Who cannot join
- None
About this study
Official title: Retrospective Review of Regional Anesthesia in Cardiac Pediatric Patients
This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.
Read the detailed description
Intra-operative anesthesia medical records of pediatric patients undergoing cardiac surgery will be acquired from July 2007 to July 2013. Allocation of regional anesthesia, and the use of spinal versus epidural versus epidural with catheter administration will be determined by provider preference. Date of surgery, age in months, gender, type of surgery, type of anesthesia, regional drugs, PaCO2 upon arrival in the PICU, time to extubation, and reintubation if applicable will be recorded. Time to extubation will be categorized into within the OR, less than 24 hours, or greater than or equal to 24 hours. PaCO2 levels will be categorized into hypercarbia (PaCO2 ≥ 50mmHg) and normal (PaCO2 < 50mmHg).
- Conditions
- Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
To expect difference in time to extubation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJul 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudhakar Subramani, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652117
- Sponsor's protocol ID
- 201212725
- Status last verified
- May 2023
- First submitted
- 7 Jan 2016
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fawcett WJ, Edwards RE, Quinn AC, MacDonald IA, Hall GM. Thoracic epidural analgesia started after cardiopulmonary bypass. Adrenergic, cardiovascular and respiratory sequelae. Anaesthesia. 1997 Apr;52(4):294-9. doi: 10.1111/j.1365-2044.1997.80-az0088.x.
PubMed 9135178Liu S, Carpenter RL, Neal JM. Epidural anesthesia and analgesia. Their role in postoperative outcome. Anesthesiology. 1995 Jun;82(6):1474-506. doi: 10.1097/00000542-199506000-00019. No abstract available.
PubMed 7793661
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Regional Anesthesia in Cardiac Pediatric Patients
- ClinicalTrials.gov ID
- NCT02652117
- Acronym / sponsor ID
- 201212725
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jan 2016 (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.
This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.
Detailed description
Intra-operative anesthesia medical records of pediatric patients undergoing cardiac surgery will be acquired from July 2007 to July 2013. Allocation of regional anesthesia, and the use of spinal versus epidural versus epidural with catheter administration will be determined by provider preference. Date of surgery, age in months, gender, type of surgery, type of anesthesia, regional drugs, PaCO2 upon arrival in the PICU, time to extubation, and reintubation if applicable will be recorded. Time to extubation will be categorized into within the OR, less than 24 hours, or greater than or equal to 24 hours. PaCO2 levels will be categorized into hypercarbia (PaCO2 ≥ 50mmHg) and normal (PaCO2 < 50mmHg).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cardiac Pediatric Patients less than 5 years old
Key inclusion criteria (1 listed)
- Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To expect difference in time to extubation
Time frame: 24 hours
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 16 May 2023.
- Background: PubMed 9135178Fawcett WJ, Edwards RE, Quinn AC, MacDonald IA, Hall GM. Thoracic epidural analgesia started after cardiopulmonary bypass. Adrenergic, cardiovascular and respiratory sequelae. Anaesthesia. 1997 Apr;52(4):294-9. doi: 10.1111/j.1365-2044.1997.80-az0088.x.
- Background: PubMed 7793661Liu S, Carpenter RL, Neal JM. Epidural anesthesia and analgesia. Their role in postoperative outcome. Anesthesiology. 1995 Jun;82(6):1474-506. doi: 10.1097/00000542-199506000-00019. No abstract available.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Sudhakar Subramani, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Iowa.
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 1 inclusion and 1 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
To expect difference in time to extubation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652117, which also lists 2 linked publications.
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 16 May 2023.