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Airway Clearance Using Non-Invasive Oscillating Device

Primary Purpose

Respiratory Insufficiency

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

NIOD Frequencer

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Chest Physiotherapy, Non-invasive, Oscillation, Secretion

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIOD Frequencer of 40Hz

NIOD Frequencer of 60Hz

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes of blood pressures (mmHg)

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)

EtCO2 and its waveform.

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.

Change of heart rates (beat per minute)

Change of oxygen saturations (%)

Change of respiratory rate (times per minute)

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.

Change of level of work of breathing (i.e., no WOB, mild, moderate, and severe).

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.

Full Information

NCT ID

NCT03821389

First Posted

January 17, 2019

Last Updated

March 16, 2020

Sponsor

St. Justine's Hospital

Collaborators

MedTeq

1. Study Identification

Unique Protocol Identification Number

NCT03821389

Brief Title

Airway Clearance Using Non-Invasive Oscillating Device

Official Title

Airway Clearance Using Non-Invasive Oscillating Device in Critically Ill Children

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Justine's Hospital

Collaborators

MedTeq

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency

Keywords

Chest Physiotherapy, Non-invasive, Oscillation, Secretion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NIOD Frequencer of 40Hz

Arm Type

Experimental

Arm Description

Arm Title

NIOD Frequencer of 60Hz

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

NIOD Frequencer

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean changes in respiratory tidal volume

Description

Tidal volume will be measured by non-invasive 3D system for non-intubated patients and ventilator for intubated patients.

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.

Secondary Outcome Measure Information:

Title

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).

Title

Estimated lung volume

Description

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.

Title

EtCO2 and its waveform.

Time Frame

Baseline: before the procedure, Comparison: two minutes from the beginning of the procedure

Title

Clinical Respiratory severity scores

Description

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.

Title

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).

Title

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).

Title

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).

Title

Change of neurological status (i.e., patient comfort level).

Description

Use COMFORT-B Scale. Score scale: 1-35, higher scale indicates that patients is more agitated and uncomfortable.

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.

Title

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.

Title

Lung air distribution

Description

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.

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.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Atsushi Kawaguchi

Phone

5149124247

atsushi@ualberta.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Lucy Clayton

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Atsushi Kawaguchi

Organizational Affiliation

St. Justine's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33020101

Citation

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.

Results Reference

derived

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Airway Clearance Using Non-Invasive Oscillating Device

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