Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis
• Intervention / Treatment: Procedure: Casting

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in appearance of flow-volume loop	Change in appearance of flow-volume loop, during the casting application as well as serial compliance measurements during the course of the casting treatment Change in appearance of flow-volume loop, during the casting application as well as serial compliance measurements during the course of the casting treatment	up to 60 months
Correlate the change in compliance with the amount of traction applied during the casting application	(in respiratory physiology) a measure of distensibility of the lung volume produced by a unit pressure change with the amount of pounds of traction applied.	up to 60 months
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	Comparison of Respiratory measurements from the Philips Spirometry Module, consisting of: lung compliance, tidal volume, peak inspiratory pressure, flow volume loop, airway resistance in Scoliosis Patients compared to healthy normal patients	up to 60 months

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Tyler W Christman, DO, Indiana University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: August 29, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Casting; Pulmonary Compliance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 1503944048