SDR Monitoring in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

SDR Monitoring in Children With Cerebral Palsy - a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079362
• Other study ID #: SDR
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: January 2, 2018
• Start date: January 15, 2007
• Est. completion date: December 2, 2015

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2, 2015
• Est. primary completion date: November 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

• Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring

Exclusion Criteria:

• > 21 years

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure		During the operation
Secondary	Intensive care unit length of stay		Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Ready to discharge	Measured Pads-Score	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Duration of ventilation	Measured in days and hours	Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Secondary	Pain	Measured by scales	Up to 12 months
Secondary	Organ complications		Up to 12 months
Secondary	Adverse reactions of pain therapy		Up to 12 months
Secondary	Therapy of adverse reactions of pain therapy		Up to 12 months
Secondary	Infections		Up to 12 months
Secondary	Delirium	Measured by Nu-DESC	Up to 12 months
Secondary	Routine laboratory		Up to 12 months
Secondary	Pain therapy		Up to 12 months
Secondary	Temperature		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Satisfaction with pain therapy	Rating scale	Up to 12 months
Secondary	Positional control of epiperidural catheter		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Reoperations		Up to 12 months
Secondary	Gross motor function measure		Up to 12 months
Secondary	Gait analysis instrumented three dimensional		Up to 12 months
Secondary	Strength		Up to 12 months
Secondary	Spasticity		Up to 12 months
Secondary	Range of motion		Up to 12 months
Secondary	Gait		Up to 12 months
Secondary	Functions scores		Up to 12 months
Secondary	Gross motor function classification system		Up to 12 months
Secondary	Modified Ashworth Scale		Up to 12 months