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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Riley Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

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:

  1. Prior to the removal of the old cast, if applicable
  2. After removal of old cast, if applicable
  3. In frame, pre-traction
  4. In frame, in traction
  5. Post-body cast application (prior to cast windows; in traction)
  6. Post cast application in bed out of traction (prior to cutting out windows)
  7. Post-cast windows cut out (in bed, prior to return of spontaneous ventilation)

The data collection will include the following physiologic parameters:

  1. Non-invasive blood pressure
  2. Heart rate
  3. Oxygen saturation
  4. 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.
  5. Respiratory measurements from the Philips Spirometry Module, consisting of:
  6. lung compliance
  7. tidal volume
  8. peak inspiratory pressure
  9. flow volume loop
  10. 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

  1. Premedication: 0.5mg/kg midazolam PO (max 15mg), PRN
  2. Induction: Mask with sevoflurane in oxygen
  3. Secure Intravenous Access
  4. Intubation: Propofol 3-4mg/kg IV. Oral endotracheal tube.
  5. Ventilation: Controlled using volume mode at 8ml/kg
  6. Maintenance: oxygen, sevoflurane, controlled ventilation
  7. 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.

  1. 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)
  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.

  1. First posted24 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2018
  4. Study completionJun 2018

Resources

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)
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 16129750
  • Jensen RD: Cardiorespiratory Effects of Derotational Casting during Anesthesia for Children with Early Onset Scoliosis4: 36-40, OJA, 2014

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.

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