Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

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. 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:

        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:

             1. lung compliance

             2. tidal volume

             3. peak inspiratory pressure

             4. flow volume loop

             5. 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
    

Intervention name(s): Casting
Intervention type(s): Procedure
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Keywords: Pulmonary Compliance; Casting