Non-Invasive Respiratory Monitoring for Cerebral Palsy

Overseen By Tariq Rahman, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

250 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment pneuRIP for non-invasive respiratory monitoring in cerebral palsy?

The pneuRIP monitor, which uses respiratory inductance plethysmography (RIP), has been shown to accurately measure breathing patterns and respiratory effort in children and infants with other conditions, such as Duchenne muscular dystrophy and in preterm infants, suggesting it could be effective for monitoring respiratory function in cerebral palsy as well. ^{1 2 3 4 5}

Is non-invasive respiratory monitoring using respiratory inductance plethysmography (RIP) safe for humans?

The studies on respiratory inductance plethysmography (RIP) suggest it is a non-invasive and generally safe method for monitoring breathing patterns in humans, as it has been tested in various settings without reports of harm. ^{1 6 7 8 9}

How does non-invasive respiratory monitoring differ from other treatments for cerebral palsy?

Non-invasive respiratory monitoring using respiratory inductive plethysmography (RIP) is unique because it allows for continuous, real-time assessment of breathing patterns without the need for invasive procedures or patient cooperation, which is particularly beneficial for individuals with cerebral palsy who may have difficulty with traditional respiratory assessments. ^{2 5 10 11 12}

What is the purpose of this trial?

This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

Research Team

Tariq Rahman, PhD

Principal Investigator

Principal Research Engineer

Eligibility Criteria

This trial is for children with severe cerebral palsy, specifically those who are classified at GMFCS levels IV or V, indicating they have significant physical limitations. The study aims to help detect respiratory issues and understand the link between lung function and scoliosis in these patients.

Inclusion Criteria

I have cerebral palsy with significant mobility limitations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Non-invasive measurement of pulmonary function using the pneuRIP sensor in children with cerebral palsy

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after measurement

4 weeks

Treatment Details

Interventions

• pneuRIP

Trial Overview The trial is testing a new non-invasive respiratory sensor called pneuRIP. It's designed as a screening tool to identify breathing difficulties in kids with cerebral palsy and to explore how their lung health relates to spine curvature caused by scoliosis.

Participant Groups

Group I: cerebral palsy group Experimental Treatment 1 Intervention

Respiratory sensor will measure breathing in patients with Cerebral palsy

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The new noninvasive pulmonary function instrument, pneuRIPTM, effectively measures respiratory work in children and shows promising accuracy compared to the existing Respitrace system, particularly in counting breaths under both normal and loaded breathing conditions.

In tests with ten normal children, pneuRIPTM demonstrated significantly better accuracy in measuring breathing rate, achieving 13.2% accuracy for normal breathing and 16.9% for loaded breathing, compared to Respitrace's 36.4% and 60.7%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

pneuRIPTM: A Novel Respiratory Inductance Plethysmography Monitor. Rahman, T., Page, R., Page, C., et al.[2020]

The qualitative diagnostic calibration (QDC) method allows for accurate calibration of respiratory inductive plethysmography (RIP) to measure tidal volume in healthy full-term newborns, demonstrating its potential for noninvasive monitoring of breathing patterns.

RIP calibrated with QDC provides clinically acceptable tidal volume measurements in both supine and prone positions, showing no significant differences in accuracy during active or quiet sleep, which is important for safe monitoring in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tidal volume measurements in newborns using respiratory inductive plethysmography. Adams, JA., Zabaleta, IA., Stroh, D., et al.[2007]

The pneuRIPTM system is a noninvasive, wireless tool that can quickly assess respiratory function in children, showing 100% compliance in a clinical setting with tests completed in under 10 minutes.

Children with Duchenne Muscular Dystrophy (DMD) exhibited significantly abnormal respiratory patterns compared to healthy peers, indicated by elevated thoracoabdominal asynchrony and work of breathing indices, highlighting the potential of pneuRIPTM for early detection of respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic differences in respiratory breathing patterns and work of breathing indices in children with Duchenne muscular dystrophy. Ryan, L., Rahman, T., Strang, A., et al.[2020]

This study compiled normative data for respiratory inductance plethysmography (RIP) across a wide age range of pediatric subjects, addressing a gap in existing research that lacked comprehensive age-matched values.

The derived regression equations from this data will enable caregivers to assess pediatric RIP measurements against established norms, facilitating the identification of pulmonary complications and improving respiratory therapy guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-related ranges of respiratory inductance plethysmography (RIP) reference values for infants and children. Balasubramaniam, SL., Wang, Y., Ryan, L., et al.[2019]

Respiratory inductance plethysmography (RIP) provides consistent and reproducible measurements of tidal volume in healthy preterm infants over an extended period of approximately 5 hours, without the need for recalibration.

The study demonstrated a significant linear relationship between tidal volume measured by a pneumotachometer and the sum of rib cage and abdominal motion signals from RIP, indicating that RIP can effectively monitor respiratory effort in various conditions without being affected by the infants' position or routine care activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Brooks, LJ., DiFiore, JM., Martin, RJ.[2019]

The study developed a new technique for adjusting the calibration of portable respiratory inductive plethysmography (RIP) using position sensor feedback, allowing for accurate monitoring of breathing patterns in unrestrained subjects, including healthy individuals and patients with lung disease.

With this new calibration method, the RIP showed a minor mean difference in tidal volume measurements compared to traditional methods, indicating high accuracy and improved precision during various body positions, making it a valuable tool for studying respiratory physiology in everyday activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory monitoring by inductive plethysmography in unrestrained subjects using position sensor-adjusted calibration. Brüllmann, G., Fritsch, K., Thurnheer, R., et al.[2009]

Respiratory inductive plethysmography (RIP) using the Respitrace Plus monitor showed that while it can measure tidal volumes (VT) in patients, it was not consistently accurate, especially in patients with COPD, where deviations were significantly higher compared to those with normal pulmonary function or acute lung injury (ALI).

The accuracy of RIP for measuring changes in end-expiratory lung volume (deltaEELV) was also limited, with only 25.8% and 46.2% of measurements being precise within +/-10% and +/-20%, respectively, indicating that RIP may not be reliable for quantitative evaluations in patients with respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory inductive plethysmography in controlled ventilation: measurement of tidal volume and PEEP-induced changes of end-expiratory lung volume. Neumann, P., Zinserling, J., Haase, C., et al.[2020]

The study developed a reference-free adjustment method for respiratory inductance plethysmography (RIP) that significantly improves the accuracy of measuring breathing characteristics, achieving 84.69% of breaths within 20% limits of equivalence compared to only 43.63% with existing methods requiring simultaneous flowmeter data.

Using only the rib cage band for RIP measurements yielded better results than using both bands, indicating that a simpler setup can still provide reliable tidal volume measurements, which enhances the potential for RIP use in various ambulatory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reference-Free Adjustment of Respiratory Inductance Plethysmography for Measurements during Physical Exercise. Leutheuser, H., Heyde, C., Roecker, K., et al.[2018]

Respiratory inductive plethysmography (RIP) is an effective method for continuous monitoring of respiratory parameters in conscious, non-restrained dogs, allowing for extended observation without the need for restraint.

RIP demonstrated comparable accuracy to traditional methods, detecting expected changes in respiratory function after administering respiratory stimulants and depressants, thus enhancing the safety evaluation of new drugs in preclinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory inductive plethysmography as a method for measuring ventilatory parameters in conscious, non-restrained dogs. Murphy, DJ., Renninger, JP., Schramek, D.[2013]

A new real-time calibration system for respiratory inductive plethysmography (RIP) allows for accurate measurement of breathing patterns in newborns without requiring complex maneuvers, achieving a high correlation with actual airflow measurements (mean correlation coefficient of 0.97).

This calibration method is quick, taking about 21 seconds, and remains stable and reliable for up to 3.5 hours, making it particularly suitable for monitoring infants during natural sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated, real-time calibration of the respiratory inductance plethysmograph and its application in newborn infants. Bar-Yishay, E., Putilov, A., Einav, S.[2019]

Calibration of the respiratory inductive plethysmograph (RIP) in premature infants under 1,500 g was only successful in 25% of cases, indicating low reliability for measuring tidal volumes in this population.

Attempts to improve calibration accuracy through dead space loading or air injection did not yield better results, suggesting that the inherent challenges of small tidal volumes and compliant rib cages limit the effectiveness of RIP in these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory inductive plethysmography in infants weighing less than 1,500 grams. Wilkes, DL., Revow, M., Bryan, MH., et al.[2006]

The study demonstrated that a respiratory inductive plethysmograph (RIP) can accurately measure breathing patterns in lambs after inducing acute pulmonary edema with oleic acid, validating its use as a tool for assessing lung injury.

The calibration technique used for RIP was efficient, with 99.9% of breaths measured within 20% accuracy compared to a standard pneumotachograph, indicating that RIP is a reliable method for respiratory assessment in experimental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing patterns in lambs after oleic acid lung injury utilizing respiratory inductive plethysmography. Warren, RH., Alderson, SH.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

pneuRIPTM: A Novel Respiratory Inductance Plethysmography Monitor. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Tidal volume measurements in newborns using respiratory inductive plethysmography. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Diagnostic differences in respiratory breathing patterns and work of breathing indices in children with Duchenne muscular dystrophy. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Age-related ranges of respiratory inductance plethysmography (RIP) reference values for infants and children. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Respiratory monitoring by inductive plethysmography in unrestrained subjects using position sensor-adjusted calibration. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory inductive plethysmography in controlled ventilation: measurement of tidal volume and PEEP-induced changes of end-expiratory lung volume. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Reference-Free Adjustment of Respiratory Inductance Plethysmography for Measurements during Physical Exercise. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Respiratory inductive plethysmography as a method for measuring ventilatory parameters in conscious, non-restrained dogs. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Automated, real-time calibration of the respiratory inductance plethysmograph and its application in newborn infants. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory inductive plethysmography in infants weighing less than 1,500 grams. [2006]

12. United States pubmed.ncbi.nlm.nih.gov

Breathing patterns in lambs after oleic acid lung injury utilizing respiratory inductive plethysmography. [2019]