Spinal FusionNCT01235650
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
An observational study of Spinal Fusion, run by Nationwide Children's Hospital.
Trial summary
This is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Fusion
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Spinal fusion patients
Who may be able to join
- Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis
Who cannot join
- None
About this study
This is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation.
Read the detailed description
Retrospective review of the operative schedules to identify patients who have undergone spinal fusion with placement of an arterial cannula for intermittent arterial blood gas analysis. The intraoperative records will be retrospectively reviewed. The following demographic data will be recorded: age, weight, gender, and co-morbid medical conditions. Ventilatory parameters at the time of ABG analysis will include (respiratory rate and tidal volume). ABG data will be collected.
- Conditions
- Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal fusion | Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inadvertent hyperventilation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235650
- Sponsor's protocol ID
- IRB10-00390
- Status last verified
- Jan 2012
- First submitted
- 4 Nov 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
- ClinicalTrials.gov ID
- NCT01235650
- Acronym / sponsor ID
- IRB10-00390
- Conditions
- Spinal Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Nov 2010 (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 is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation.
Detailed description
Retrospective review of the operative schedules to identify patients who have undergone spinal fusion with placement of an arterial cannula for intermittent arterial blood gas analysis. The intraoperative records will be retrospectively reviewed. The following demographic data will be recorded: age, weight, gender, and co-morbid medical conditions. Ventilatory parameters at the time of ABG analysis will include (respiratory rate and tidal volume). ABG data will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal fusion | – | –Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal fusion patients
Key inclusion criteria (1 listed)
- Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis
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
Incidence of inadvertent hyperventilation
Time frame: Day 1
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 31 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion, run by Nationwide Children's Hospital.
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 31 Jan 2012. 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?
Incidence of inadvertent hyperventilation (time frame: Day 1). 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 31 Jan 2012.