Airway Clearance Using Non-Invasive Oscillating Device

March 16, 2020 updated by: Atsushi Kawaguchi, St. Justine's Hospital

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lucy Clayton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIOD Frequencer of 40Hz
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.
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.
Active Comparator: NIOD Frequencer of 60Hz
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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)
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
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.
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.
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).
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).
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).
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.
Use COMFORT-B Scale. Score scale: 1-35, higher scale indicates that patients is more agitated and uncomfortable.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Atsushi Kawaguchi, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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