Airway Clearance Using Non-Invasive Oscillating Device

NCT03821389 | Unknown Phase 2 DMC

• 1 other identifier: 000
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Insufficiency

Keywords

Chest Physiotherapy; Non-invasive; Oscillation; Secretion

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  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.

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

• Clinical Respiratory severity scores

  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)

  from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).

Study Arms (2)

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.

Device: NIOD Frequencer

NIOD Frequencer of 60Hz

ACTIVE COMPARATOR

Device: NIOD Frequencer

Interventions

NIOD Frequencer DEVICE

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.

NIOD Frequencer of 40Hz; NIOD Frequencer of 60Hz

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• MedTeq: collaborator

Related Publications (1)

• 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.

  PMID: 33020101 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Atsushi Kawaguchi

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atsushi Kawaguchi

CONTACT

5149124247; atsushi@ualberta.ca

Lucy Clayton

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 29, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share