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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to monitor breathing problems in children with severe cerebral palsy using a non-invasive sensor called pneuRIP (Respiratory Inductance Plethysmography monitor). The main goals are to develop a tool that can detect breathing troubles early and to determine if a link exists between breathing issues and scoliosis (a spine curve) in these children. It suits children diagnosed with cerebral palsy who have severe movement limitations affecting daily life. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could significantly enhance the quality of life for children with severe cerebral palsy.

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 prior data suggests that this non-invasive respiratory sensor is safe for children with cerebral palsy?

Research has shown that respiratory inductance plethysmography (RIP) safely and non-invasively monitors breathing patterns. The pneuRIP system uses RIP to wirelessly track breathing. Studies indicate that this method is well-tolerated, with people typically experiencing no side effects or discomfort. Researchers have tested and developed it for various settings, making it a promising tool for safely monitoring breathing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pneuRIP because it offers a non-invasive way to monitor breathing in patients with cerebral palsy. Unlike traditional methods that might involve more direct and potentially uncomfortable interventions, pneuRIP uses a respiratory sensor to measure breathing without needing to physically penetrate the body. This approach could provide real-time data and improve the comfort and safety of patients, offering a new level of insight into respiratory function that current methods might not capture as effectively.

What evidence suggests that the pneuRIP is effective for monitoring respiratory distress in cerebral palsy?

Research shows that pneuRIP, a non-invasive breathing sensor, can effectively track breathing patterns in people, including those with cerebral palsy. Studies have found that this technology, which uses a method called RIP, is generally safe and provides accurate information on breathing. Previous tests of pneuRIP demonstrated that most people use it easily and it works well, suggesting it can be a reliable tool for spotting breathing problems. This trial will evaluate pneuRIP in patients with cerebral palsy, offering promise for helping children by identifying breathing difficulties and possibly linking these issues to scoliosis. ^{2 3 6 7 8}

Who Is on the Research Team?

Tariq Rahman, PhD

Principal Investigator

Principal Research Engineer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-cerebral-palsy-4-2023-a9999

Non-Invasive Respiratory Monitoring for Cerebral Palsy The studies on respiratory inductance plethysmography (RIP) suggest it is a non-invasive and generally safe method for monitoring breathing patterns in humans, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9934911/

A Descriptive Study of Speech Breathing in Children With ... Based on descriptive results, children with CP and speech motor involvement demonstrated reduced utterance length and speech rate, equivalent ...

3. researchgate.net researchgate.net/publication/311852658_pneuRIPTM_A_Novel_Respiratory_Inductance_Plethysmography_Monitor

(PDF) pneuRIP(TM): A Novel Respiratory Inductance ... In this paper, the development and testing of a new noninvasive PF instrument, pneuRIPTM, which utilizes respiratory inductance plethysmography ...

4. scientia.global scientia.global/dr-thomas-shaffer-dr-tariq-rahman-innovative-new-technology-to-monitor-childrens-breathing/

Dr Thomas Shaffer - Dr Tariq Rahman | Innovative New ... With such high compliance rates and a plethora of positive results with the pneuRIPTM technology, Dr Shaffer and Dr Rahman will now test it out ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9132159/

Comparison of Respiratory Calibration Methods for the ... The primary purpose of this study was to validate common respiratory calibration methods for estimating lung volume in children.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5318692/

A Novel Respiratory Inductance Plethysmography Monitor The pneuRIPTM system can wirelessly receive RIP data from the patient, display relevant data on the screen instantly, and has the potential to securely e ...

7. esmed.org esmed.org/MRA/mra/article/download/2594/193545954/

Respiratory System Impairments in Children with Cerebral ... Introduction. Cerebral palsy (CP) is the most common physical disability of childhood with a general incidence of 2.11/1000 live births.

8. mdpi.com mdpi.com/2075-4418/11/5/880

Automated Assessment of Thoracic-Abdominal Asynchrony ... Respiratory inductance plethysmography (RIP) is a noninvasive method that can be used to assess respiratory function by recording the rib cage ( ...