Respiratory DecompensationPERKINENCT07473856
Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities
A study testing Intrapulmonary Percussive Ventilation IPV in people with Respiratory Decompensation and Multiple Disabilities, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Respiratory Decompensation, Multiple Disabilities
- What is being tested?
- Intrapulmonary Percussive Ventilation IPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Polyhandicap defined by:
- Causal brain injury or lesion occurring before the age of 3 years,
- Severe or profound intellectual disability according to DSM IV definition
- Motor disability: paraplegia/quadriplegia, hemiparesis, ataxia, and/or extrapyramidal motor disorders,
- Gross Motor Function Classification System (GMFCS) score of IV or V,
- Functional Independence Measure (FIM) score < 55,
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- Age: 1 to 16 years,
- Hospitalization of the patient with respiratory decompensation (RD),
- Informed consent from parents/legal guardians
Who cannot join
- Associated neuromuscular disease
- Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,
- Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,
- Contraindications for the use of the medical device:
- Pneumothorax,
- Hypotension or hemodynamic instability,
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- Hemoptysis,
- Participation in another interventional study.
- Patients with tracheobronchial collapse during expiration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Name Pediatric Pulmonology Department - Armand Trousseau Hospital
Paris, 75012
Jessica TAYTARD, MCU-PH, +33 (0)1 71 73 87 11, jessica.taytard@aphp.fr
Charlotte THEBAULT, 00 33 6.65.80.72.55, charlotte.thebault@aphp.fr
About this study
Official title: Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities: A Multicenter Randomized Controlled Trial.
Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.
Respiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and/or instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.
Read more
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:
- Control group: manual respiratory physiotherapy.
- Intervention group: intrapulmonary Percussive Ventilation (IPV)
Read the detailed description
IPV is used in France in different ways, depending on the center and service practices, as a complement to manual techniques.
At Armand Trousseau University Hospital, our experience over the past five years with more than 50 children suggests that the use of IPV by carers in their home environment. This is done as a complement to private manual physiotherapy sessions after training by a professional.
However, the benefits and impact of IPV on patients' respiratory development remain largely unstudied, particularly in patients with multiple disabilities. This multicenter randomized controlled study could provide recommendations for the respiratory management of these patients.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV in the home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone. The primary endpoint is the number of rehospitalizations for RD at 18 months following the index hospitalization.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with Respiratory Decompensation (RD). the patient will be randomized into one of the two study groups:
- Control group:
- Intervention group: the use of IPV will be initiated during hospitalization. The total duration of the study is planned to be 36 months, Follow-up visits will be scheduled at 1, 3, 6, 12 and 18 months for both groups. In order to avoid adding too many trips for these families, who are often very busy, visits will be scheduled at the same time as routine medical and paramedical consultations whenever possible. Certain visits that cannot be synchronized with routine follow-up consultations will be conducted via videoconference or telephone calls by the study investigators.
An adjudication committee will validate respiratory decompensation following rehospitalization that may occur within 18 months of the child's inclusion/randomization in the PERKINE protocol. They will remain blinded to the child's randomization group until the end of the study.
Analysis will be performed at the end of the study after data review and before database lock
- Conditions
- Respiratory Decompensation, Multiple Disabilities
- Being tested
- Intrapulmonary Percussive Ventilation IPV
- Keywords
- Polyhandicap, Intrapulmonary Percussive Ventilation, Respiratory distress, Rehospitalization with respiratory decompensation, Quality of life (PolyQol), Exacerbation management at home
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapulmonary Percussive Ventilation IPVProcedure or surgery
Also called Comfort Cough II®, Percussion Ventilation Device
After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.
| Study group | Role | What they receive |
|---|---|---|
| IPV + Manual Respiratory Physiotherapy | Experimental | After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home. Receives: Procedure: Intrapulmonary Percussive Ventilation IPV |
| Manual Respiratory Physiotherapy Only | No intervention | no intervention, current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of readmissions with respiratory decompensation
Measured: 18 months after the index hospitalization with respiratory decompensation
Secondary outcomes (6)
Number of days of hospitalization
Hospital days with respiratory decompensation in conventional service and in the intensive Care Unit
Measured: 18 months after the index hospitalization with respiratory decompensation.
Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations
Measured: 18 months after the index hospitalization with respiratory decompensation.
Number of days on antibiotics for respiratory issues
Track antibiotic use for respiratory conditions outside of baseline treatment
Measured: 18 months after the index hospitalization with respiratory decompensation.
PolyQol scale
change in the child's quality of life using the PolyQol scale
Measured: At month 1, month 3, month 6, month 12, and month 18
PERKINE Questionnaire
Evaluation of caregivers' perceptions of the child's respiratory status and the feasibility, tolerance, efficacy, and adherence to conventional respiratory physiotherapy versus PPV using the PERKINE questionnaire
Measured: At month 1, month 3, month 6, month 12, and month 18
Cost-Effectiveness Analysis
Evaluate the incremental cost-effectiveness ratio (ICER) of IPV at home compared to usual care cost
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DecompensationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica TAYTARD, MCU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473856
- Sponsor's protocol ID
- APHP240805
- Other IDs
- IDRCB 2025-A01388-41
- Acronym
- PERKINE
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities: A Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07473856
- Acronym / sponsor ID
- PERKINE / APHP240805
- Conditions
- Respiratory Decompensation, Multiple Disabilities
- Keywords
- Polyhandicap, Intrapulmonary Percussive Ventilation, Respiratory distress, Rehospitalization with respiratory decompensation, Quality of life (PolyQol), Exacerbation management at home
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.
Respiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and/or instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:
- Control group: manual respiratory physiotherapy.
- Intervention group: intrapulmonary Percussive Ventilation (IPV)
Detailed description
IPV is used in France in different ways, depending on the center and service practices, as a complement to manual techniques.
At Armand Trousseau University Hospital, our experience over the past five years with more than 50 children suggests that the use of IPV by carers in their home environment. This is done as a complement to private manual physiotherapy sessions after training by a professional.
However, the benefits and impact of IPV on patients' respiratory development remain largely unstudied, particularly in patients with multiple disabilities. This multicenter randomized controlled study could provide recommendations for the respiratory management of these patients.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV in the home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone. The primary endpoint is the number of rehospitalizations for RD at 18 months following the index hospitalization.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with Respiratory Decompensation (RD). the patient will be randomized into one of the two study groups:
- Control group:
- Intervention group: the use of IPV will be initiated during hospitalization. The total duration of the study is planned to be 36 months, Follow-up visits will be scheduled at 1, 3, 6, 12 and 18 months for both groups. In order to avoid adding too many trips for these families, who are often very busy, visits will be scheduled at the same time as routine medical and paramedical consultations whenever possible. Certain visits that cannot be synchronized with routine follow-up consultations will be conducted via videoconference or telephone calls by the study investigators.
An adjudication committee will validate respiratory decompensation following rehospitalization that may occur within 18 months of the child's inclusion/randomization in the PERKINE protocol. They will remain blinded to the child's randomization group until the end of the study.
Analysis will be performed at the end of the study after data review and before database lock
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPV + Manual Respiratory Physiotherapy | Experimental | Procedure: Intrapulmonary Percussive Ventilation IPVAfter the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home. |
| Manual Respiratory Physiotherapy Only | No intervention | –no intervention, current practice |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Polyhandicap defined by:
- Age: 1 to 16 years,
- Hospitalization of the patient with respiratory decompensation (RD),
- Informed consent from parents/legal guardians
Key exclusion criteria (9 listed)
- Associated neuromuscular disease
- Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,
- Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,
- Contraindications for the use of the medical device:
- Participation in another interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapulmonary Percussive Ventilation IPVAlso: Comfort Cough II®, Percussion Ventilation DeviceAfter the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home. | Procedure or surgery | IPV + Manual Respiratory Physiotherapy |
Primary outcome
Number of readmissions with respiratory decompensation
Time frame: 18 months after the index hospitalization with respiratory decompensation
6 secondary outcomes
Number of days of hospitalization
Time frame: 18 months after the index hospitalization with respiratory decompensation.
Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations
Time frame: 18 months after the index hospitalization with respiratory decompensation.
Number of days on antibiotics for respiratory issues
Time frame: 18 months after the index hospitalization with respiratory decompensation.
PolyQol scale
Time frame: At month 1, month 3, month 6, month 12, and month 18
PERKINE Questionnaire
Time frame: At month 1, month 3, month 6, month 12, and month 18
Cost-Effectiveness Analysis
Time frame: At the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Respiratory Decompensation
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
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Not yet recruiting
The SHAPE Project (Hospital System for Physical Activity and Active Participation) After Hospitalized Decompensation of Respiratory Chronic Diseases
Frailty, Sarcopenia
RecruitingObservational study
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
Pre-Term, Respiratory Distress of Newborn
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica TAYTARD, MCU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapulmonary Percussive Ventilation IPV in people with Respiratory Decompensation and Multiple Disabilities, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica TAYTARD, MCU-PH (+33 (0)1 71 73 87 11, jessica.taytard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of readmissions with respiratory decompensation (time frame: 18 months after the index hospitalization with respiratory decompensation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.