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

NCT02558985 | Completed

• 1 other identifier: 1503944048
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Pulmonary Compliance; Casting

Outcome Measures

Primary Outcomes (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.

  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

  up to 60 months

Other Outcomes (3)

• Change in appearance of flow-volume loop

  up to 60 months

• Correlate the change in compliance with the amount of traction applied during the casting application

  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

  up to 60 months

Interventions

Casting PROCEDURE

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.

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Clinical diagnosis of Progressive Early Onset Scoliosis
• 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

You may not qualify if:

• Known contraindication to the general anesthesia

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• 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.

  PMID: 16129750 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Scoliosis; Patient Compliance

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tyler W Christman, DO

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 24, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)