Clinical trial NCT02558985: Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Official title: Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Pulmonary Compliance
Casting
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
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.

Brief 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

• Known contraindication to the general anesthesia

Primary outcomes:
measure: Change in lung parameters for an individual patient as his/her own control During each casting and the duration of casting treatment.
timeFrame: up to 60 months
Secondary outcomes:
measure: Measure the oxygen saturation from post-induction baseline during the casting application as well as serial compliance measurements
timeFrame: up to 60 months
Other outcomes:
measure: Change in appearance of flow-volume loop
timeFrame: up to 60 months
measure: Correlate the change in compliance with the amount of traction applied during the casting application
timeFrame: up to 60 months
measure: Compare scoliosis casting patient data to healthy patients' lung compliance, during the casting application as well as serial compliance measurements during the course of the casting treatment
timeFrame: up to 60 months
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Tyler W Christman, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jensen RD: Cardiorespiratory Effects of Derotational Casting during Anesthesia for Children with Early Onset Scoliosis4: 36-40, OJA, 2014