ScoliosisNCT02558985
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
An observational study of Scoliosis, run by Indiana University at 1 site in United States.
Trial summary
No interventions outside the normal course of patient care. The investigators will be collecting data at specified points throughout the casting process. The proposed study will measure lung compliance during the casting process for spinal manipulation. Read more about this study
- Who is it for?
- Ages 6 months to 9 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Casting
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2018
- 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 6 months to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Any patients 6 months to 9 years of age with progressive Early Onset Scoliosis who present for serial thoracolumbar casting and spine manipulation at Riley Hospital for Children will be invited to participate.
Who may be able to join
- Clinical diagnosis of Progressive Early Onset Scoliosis
- 6 months to 9 years of age
- Must be able to present for serial thoracolumbar casting and spine manipulation at Riley Hospital for Children in Indianapolis, IN
Who cannot join
- Known contraindication to the general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast
No interventions outside the normal course of patient care. The investigators will be collecting data at specified points throughout the casting process.
The proposed study will measure lung compliance during the casting process for spinal manipulation. Research questions include: Is there a quantifiable change in lung compliance during the casting process? Is there an individual change in lung compliance over time comparing collection points at each cast change? Is there a change in appearance of flow-volume loop? Is there a decrease in oxygen saturation from post-induction baseline? The investigators hypothesize that there is a change in lung compliance and a decrease in oxygen saturation during the casting process.
Read the detailed description
All patients undergoing spine manipulation and scoliosis casting will receive general anesthesia with a standard anesthetic technique regardless of if the patient is included in the study or not. The investigators will meet with the patient and the patient's parent/guardian prior to the procedure, which is traditionally done whether a patient participates in a study or not, to discuss the anesthetic plan. As part of the investigator's description of the anesthetic plan, the investigator will inform the patient and the parent/guardian of the study including the rationale for the study and the non-invasive means of obtaining data. The data will be obtained during the current cast application as well as any subsequent cast application surgeries that the patient will return for the future. A patient's cast will be changed approximately as needed per each child's circumstance; common time periods a child's cast may need to be changed include, but not limited to: growth, the cast becoming soiled, damaged, or other circumstances the study physician feels it is advisable to change the cast. The study will follow them until casting procedures are completed for treatment of scoliosis. The standard general anesthesia technique will be used. Please see Appendix A for suggested Anesthesia.
There will be seven data collection points during the patient's general anesthetic:
- Prior to the removal of the old cast, if applicable
- After removal of old cast, if applicable
- In frame, pre-traction
- In frame, in traction
- Post-body cast application (prior to cast windows; in traction)
- Post cast application in bed out of traction (prior to cutting out windows)
- Post-cast windows cut out (in bed, prior to return of spontaneous ventilation)
The data collection will include the following physiologic parameters:
- Non-invasive blood pressure
- Heart rate
- Oxygen saturation
- The amount of traction (in pounds) that the patient is placed in for the spine manipulation. This will be measured at the beginning of traction, the beginning of cast application, and at the end of cast application.
- Respiratory measurements from the Philips Spirometry Module, consisting of:
- lung compliance
- tidal volume
- peak inspiratory pressure
- flow volume loop
- airway resistance
Patients will also be subject to a chart review. The chart review will include previous anesthetic records which may provide valuable information concerning the patient's baseline lung compliance, tidal volume, peak inspiratory pressure, flow volume loop, and airway resistance, amount of traction applied and scoliosis curve correction. This previous data will be used to compare to the data collected before, during and after cast changes.
Appendix A: Suggested Anesthesia
- Premedication: 0.5mg/kg midazolam PO (max 15mg), PRN
- Induction: Mask with sevoflurane in oxygen
- Secure Intravenous Access
- Intubation: Propofol 3-4mg/kg IV. Oral endotracheal tube.
- Ventilation: Controlled using volume mode at 8ml/kg
- Maintenance: oxygen, sevoflurane, controlled ventilation
- Emergence: ondansetron 0.15mg/kg IV
- Conditions
- Scoliosis
- Being tested
- Casting
- Keywords
- Pulmonary Compliance, Casting
- Medical subject headings
- Scoliosis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastingProcedure or surgery
Serial casting is used to partially correct the deformity before beginning bracing. A cast can be considered a full-time brace which cannot be removed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung parameters for an individual patient as his/her own control During each casting and the duration of casting treatment.
Change in lung parameters for an individual patient as his/her own control, during the casting application as well as serial compliance measurements during the course of the casting treatment in both the acute and long-term phase of casting and the duration of casting. Parameters measured would include, but not limited to lung compliance, tidal volume, peak inspiratory pressure, flow volume loop, and airway resistance.
Measured: up to 60 months
Secondary outcomes (1)
Measure the oxygen saturation from post-induction baseline during the casting application as well as serial compliance measurements
Measure the percent of oxygen saturation to determine if there is a difference between initial cast application and subsequent cast applications.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionJun 2018
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 ScoliosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler William Christman, Indiana University
- Investigators
- Tyler W Christman, DO, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558985
- Sponsor's protocol ID
- 1503944048
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2015
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehta MH. Growth as a corrective force in the early treatment of progressive infantile scoliosis. J Bone Joint Surg Br. 2005 Sep;87(9):1237-47. doi: 10.1302/0301-620X.87B9.16124.
PubMed 16129750Jensen RD: Cardiorespiratory Effects of Derotational Casting during Anesthesia for Children with Early Onset Scoliosis4: 36-40, OJA, 2014
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast
- ClinicalTrials.gov ID
- NCT02558985
- Acronym / sponsor ID
- 1503944048
- Conditions
- Scoliosis
- Keywords
- Pulmonary Compliance, Casting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Sep 2015 (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.
No interventions outside the normal course of patient care. The investigators will be collecting data at specified points throughout the casting process.
The proposed study will measure lung compliance during the casting process for spinal manipulation. Research questions include: Is there a quantifiable change in lung compliance during the casting process? Is there an individual change in lung compliance over time comparing collection points at each cast change? Is there a change in appearance of flow-volume loop? Is there a decrease in oxygen saturation from post-induction baseline? The investigators hypothesize that there is a change in lung compliance and a decrease in oxygen saturation during the casting process.
Detailed description
All patients undergoing spine manipulation and scoliosis casting will receive general anesthesia with a standard anesthetic technique regardless of if the patient is included in the study or not. The investigators will meet with the patient and the patient's parent/guardian prior to the procedure, which is traditionally done whether a patient participates in a study or not, to discuss the anesthetic plan. As part of the investigator's description of the anesthetic plan, the investigator will inform the patient and the parent/guardian of the study including the rationale for the study and the non-invasive means of obtaining data. The data will be obtained during the current cast application as well as any subsequent cast application surgeries that the patient will return for the future. A patient's cast will be changed approximately as needed per each child's circumstance; common time periods a child's cast may need to be changed include, but not limited to: growth, the cast becoming soiled, damaged, or other circumstances the study physician feels it is advisable to change the cast. The study will follow them until casting procedures are completed for treatment of scoliosis. The standard general anesthesia technique will be used. Please see Appendix A for suggested Anesthesia.
There will be seven data collection points during the patient's general anesthetic:
- Prior to the removal of the old cast, if applicable
- After removal of old cast, if applicable
- In frame, pre-traction
- In frame, in traction
- Post-body cast application (prior to cast windows; in traction)
- Post cast application in bed out of traction (prior to cutting out windows)
- Post-cast windows cut out (in bed, prior to return of spontaneous ventilation)
The data collection will include the following physiologic parameters:
- Non-invasive blood pressure
- Heart rate
- Oxygen saturation
- The amount of traction (in pounds) that the patient is placed in for the spine manipulation. This will be measured at the beginning of traction, the beginning of cast application, and at the end of cast application.
- Respiratory measurements from the Philips Spirometry Module, consisting of:
- lung compliance
- tidal volume
- peak inspiratory pressure
- flow volume loop
- airway resistance
Patients will also be subject to a chart review. The chart review will include previous anesthetic records which may provide valuable information concerning the patient's baseline lung compliance, tidal volume, peak inspiratory pressure, flow volume loop, and airway resistance, amount of traction applied and scoliosis curve correction. This previous data will be used to compare to the data collected before, during and after cast changes.
Appendix A: Suggested Anesthesia
- Premedication: 0.5mg/kg midazolam PO (max 15mg), PRN
- Induction: Mask with sevoflurane in oxygen
- Secure Intravenous Access
- Intubation: Propofol 3-4mg/kg IV. Oral endotracheal tube.
- Ventilation: Controlled using volume mode at 8ml/kg
- Maintenance: oxygen, sevoflurane, controlled ventilation
- Emergence: ondansetron 0.15mg/kg IV
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any patients 6 months to 9 years of age with progressive Early Onset Scoliosis who present for serial thoracolumbar casting and spine manipulation at Riley Hospital for Children will be invited to participate.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Progressive Early Onset Scoliosis
- 6 months to 9 years of age
- Must be able to present for serial thoracolumbar casting and spine manipulation at Riley Hospital for Children in Indianapolis, IN
Key exclusion criteria (1 listed)
- Known contraindication to the general anesthesia
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 |
|---|---|---|
| CastingSerial casting is used to partially correct the deformity before beginning bracing. A cast can be considered a full-time brace which cannot be removed. | Procedure or surgery | – |
Primary outcome
Change in lung parameters for an individual patient as his/her own control During each casting and the duration of casting treatment.
Time frame: up to 60 months
Change in lung parameters for an individual patient as his/her own control, during the casting application as well as serial compliance measurements during the course of the casting treatment in both the acute and long-term phase of casting and the duration of casting. Parameters measured would include, but not limited to lung compliance, tidal volume, peak inspiratory pressure, flow volume loop, and airway resistance.
1 secondary outcome
Measure the oxygen saturation from post-induction baseline during the casting application as well as serial compliance measurements
Time frame: up to 60 months
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 24 Feb 2023.
- Background: PubMed 16129750Mehta MH. Growth as a corrective force in the early treatment of progressive infantile scoliosis. J Bone Joint Surg Br. 2005 Sep;87(9):1237-47. doi: 10.1302/0301-620X.87B9.16124.
- BackgroundJensen RD: Cardiorespiratory Effects of Derotational Casting during Anesthesia for Children with Early Onset Scoliosis4: 36-40, OJA, 2014
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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.
Tyler W Christman, DO principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Indiana University 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 3 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 24 Feb 2023. 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?
Change in lung parameters for an individual patient as his/her own control During each casting and the duration of casting treatment. (time frame: up to 60 months). 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 NCT02558985, 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 24 Feb 2023.