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

NCT ID: NCT02558985

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-06-30

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

Conditions

Scoliosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Casting

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tyler William Christman

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tyler W Christman, DO

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Riley Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16129750 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

1503944048

Identifier Type: -

Identifier Source: org_study_id