Respiratory InsufficiencyPhase 2/3NCT03821389
Airway Clearance Using Non-Invasive Oscillating Device
A Phase 2/3 study testing NIOD Frequencer in people with Respiratory Insufficiency, run by St. Justine's Hospital.
Trial summary
This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD, FrequencerTM) in critically ill children. The project is two years long with two separate stages of investigation. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- NIOD Frequencer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All the patients admitted to the PICU during the study period will be screened. The investigators will not set any restriction regarding the timing of prescription of CPT (i.e., length of PICU stay before screening) for the screening. The investigators will include only if CPT is expected to be used as a management at least for the next 24 hours in the PICU from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, the investigators will exclude the participants from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside pediatric intensivists in charge on the study date. The investigators will only include patients whose oxygenation is stable (SpO2>90%) with less than 0.60 of ventilators.
Who cannot join
- CPT order will (or is expected to) be discontinued within 24 hours from the inclusion timing.
- CPT is not ordered for airway clearance.
- SpO2 is not stable (SpO2=<90%) with more than 0.60 of FIO2 for the ventilated patients including patients on NIV, at least for previous 1 hour from the screening.
- SpO2 is not stable (SpO2=<90%) with more than 0.60 of FIO2 for the patients on HFNC, at least for previous 1 hour from the screening.
- Bradycardia (HR<80bpm) at any interventions at least for 24 hours prior to the screening.
- Patients with known pneumothorax, osteomyelitis in the PICU admission.
Show all 12Show fewer
- Known pulmonary hypertension with treatment(s) underway.
- Thoracotomy within 1 month.
- Known recent/unhealed rib fractures.
- Known skin injury of chest wall.
- No obtain of IC.
- Brain death or vegetated states.
Trial locations and contacts
No sites are listed yet.
Lucy Clayton contact
About this study
Official title: Airway Clearance Using Non-Invasive Oscillating Device in Critically Ill Children
This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD, FrequencerTM) in critically ill children. The project is two years long with two separate stages of investigation. This study specifically examines different frequencies of NIOD to find the best frequency on patients outcomes.
Read the detailed description
Airway obstruction due to excessive production of secretion in small children especially those with bronchiolitis is a critical problem in the clinical management. Chest physiotherapy (CPT) and an invasive positive percussion ventilation (IPPV) have been recognized as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proved to be sufficient. This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD) in critically ill children. The study will be prospective Crossover Randomized Study in a Pediatric Intensive Care Unit in a Canadian Academic Children's Hospital. We will target children less than 24-month-old, for whom CPT is prescribed for airway clearance with or without atelectasis. We will apply two different frequencies of NIOD (i.e. 40 and 60Hz) for 3 minutes each, on each patient 3 hours apart. The investigators will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, IPPV, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing PEEP or changing the nasal mask to total face CPAP) can be provided at the direction of bedside pediatric intensivists in charge.
- Conditions
- Respiratory Insufficiency
- Being tested
- NIOD Frequencer
- Keywords
- Chest Physiotherapy, Non-invasive, Oscillation, Secretion
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIOD FrequencerDevice
NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated (Figure1), particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the midclavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is prespecified on the machine.
| Study group | Role | What they receive |
|---|---|---|
| NIOD Frequencer of 40Hz | Experimental | 40 Hz of NIOD will be applied and then 60Hz will be used 3 hours later. 60 Hz of NIOD will be applied and then 40Hz will be used 3 hours later for the rest of the patients. The investigators will analyze the difference in average effects between 40Hz and 60Hz. Receives: Device: NIOD Frequencer |
| NIOD Frequencer of 60Hz | Active comparator | Not described Receives: Device: NIOD Frequencer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes in respiratory tidal volume
Tidal volume will be measured by non-invasive 3D system for non-intubated patients and ventilator for intubated patients.
Measured: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Secondary outcomes (10)
Changes of blood pressures (mmHg)
Measured: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Estimated lung volume
lung volume will be measured by mechanical ventilator when patients are on an invasive mechanical ventilator, or 3D non-invasive measuring system when patients are not on an invasive mechanical ventilator (reference: Computerized Medical Imaging and Graphics 70 (2018) 17-28)
Measured: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
EtCO2 and its waveform.
Measured: Baseline: before the procedure, Comparison: two minutes from the beginning of the procedure
Clinical Respiratory severity scores
Use modified Woods Score, which consists of 5 elements including 1) accessory muscle use 2) cyanosis (Y/N), 3) lung air entry, 4) level of contiousness, and 5) wheeze (Y/N). The score scales from 0-10, for which the higher score indicates higher severity of respiratory condition.
Measured: collected 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of heart rates (beat per minute)
Measured: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of oxygen saturations (%)
Measured: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of respiratory rate (times per minute)
Measured: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of neurological status (i.e., patient comfort level).
Use COMFORT-B Scale. Score scale: 1-35, higher scale indicates that patients is more agitated and uncomfortable.
Measured: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of level of work of breathing (i.e., no WOB, mild, moderate, and severe).
Measured: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Lung air distribution
lung air distribution will be measured by using EIT (electrical impedance tomography). The distribution will be examined by area of air distribution which is measured and quantified by EIT.
Measured: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MedTeq
- Responsible party
- Principal investigator, Atsushi Kawaguchi, St. Justine's Hospital
- Investigators
- Atsushi Kawaguchi, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821389
- Sponsor's protocol ID
- 000
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawaguchi A, Bernier G, Adler A, Emeriaud G, Jouvet PA. Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial. BMJ Open. 2020 Oct 5;10(10):e038648. doi: 10.1136/bmjopen-2020-038648.
PubMed 33020101
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Clearance Using Non-Invasive Oscillating Device in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03821389
- Acronym / sponsor ID
- 000
- Conditions
- Respiratory Insufficiency
- Keywords
- Chest Physiotherapy, Non-invasive, Oscillation, Secretion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- MedTeq
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jan 2019 (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.
This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD, FrequencerTM) in critically ill children. The project is two years long with two separate stages of investigation. This study specifically examines different frequencies of NIOD to find the best frequency on patients outcomes.
Detailed description
Airway obstruction due to excessive production of secretion in small children especially those with bronchiolitis is a critical problem in the clinical management. Chest physiotherapy (CPT) and an invasive positive percussion ventilation (IPPV) have been recognized as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proved to be sufficient. This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD) in critically ill children. The study will be prospective Crossover Randomized Study in a Pediatric Intensive Care Unit in a Canadian Academic Children's Hospital. We will target children less than 24-month-old, for whom CPT is prescribed for airway clearance with or without atelectasis. We will apply two different frequencies of NIOD (i.e. 40 and 60Hz) for 3 minutes each, on each patient 3 hours apart. The investigators will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, IPPV, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing PEEP or changing the nasal mask to total face CPAP) can be provided at the direction of bedside pediatric intensivists in charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIOD Frequencer of 40Hz | Experimental | Device: NIOD Frequencer40 Hz of NIOD will be applied and then 60Hz will be used 3 hours later. 60 Hz of NIOD will be applied and then 40Hz will be used 3 hours later for the rest of the patients. The investigators will analyze the difference in average effects between 40Hz and 60Hz. |
| NIOD Frequencer of 60Hz | Active comparator | Device: NIOD Frequencer |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All the patients admitted to the PICU during the study period will be screened. The investigators will not set any restriction regarding the timing of prescription of CPT (i.e., length of PICU stay before screening) for the screening. The investigators will include only if CPT is expected to be used as a management at least for the next 24 hours in the PICU from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, the investigators will exclude the participants from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside pediatric intensivists in charge on the study date. The investigators will only include patients whose oxygenation is stable (SpO2>90%) with less than 0.60 of ventilators.
Key exclusion criteria (12 listed)
- CPT order will (or is expected to) be discontinued within 24 hours from the inclusion timing.
- CPT is not ordered for airway clearance.
- SpO2 is not stable (SpO2=<90%) with more than 0.60 of FIO2 for the ventilated patients including patients on NIV, at least for previous 1 hour from the screening.
- SpO2 is not stable (SpO2=<90%) with more than 0.60 of FIO2 for the patients on HFNC, at least for previous 1 hour from the screening.
- Bradycardia (HR<80bpm) at any interventions at least for 24 hours prior to the screening.
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 |
|---|---|---|
| NIOD FrequencerNIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated (Figure1), particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the midclavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is prespecified on the machine. | Device | NIOD Frequencer of 40Hz, NIOD Frequencer of 60Hz |
Primary outcome
Mean changes in respiratory tidal volume
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Tidal volume will be measured by non-invasive 3D system for non-intubated patients and ventilator for intubated patients.
10 secondary outcomes
Changes of blood pressures (mmHg)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Estimated lung volume
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
EtCO2 and its waveform.
Time frame: Baseline: before the procedure, Comparison: two minutes from the beginning of the procedure
Clinical Respiratory severity scores
Time frame: collected 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of heart rates (beat per minute)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of oxygen saturations (%)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of respiratory rate (times per minute)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of neurological status (i.e., patient comfort level).
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of level of work of breathing (i.e., no WOB, mild, moderate, and severe).
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Lung air distribution
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 33020101Kawaguchi A, Bernier G, Adler A, Emeriaud G, Jouvet PA. Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial. BMJ Open. 2020 Oct 5;10(10):e038648. doi: 10.1136/bmjopen-2020-038648.
- Individual participant dataSharing planned: No
Related trials for Respiratory Insufficiency
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
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. This study is not recruiting at the moment.
Lucy Clayton contact
Atsushi Kawaguchi principal investigator
St. Justine's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NIOD Frequencer in people with Respiratory Insufficiency, run by St. Justine's Hospital.
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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atsushi Kawaguchi (5149124247, atsushi@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in respiratory tidal volume (time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821389, which also lists 1 linked publication.
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 17 Mar 2020.