Airway Clearance Using Non-Invasive Oscillating Device

• ClinicalTrials.gov Identifier: NCT03821389
• Recruitment Status: Not yet recruiting
• First Posted: January 29, 2019
• Last Update Posted: March 17, 2020
• Sponsor: St. Justine's Hospital
• Collaborator: MEDTEQ
• Information provided by (Responsible Party): Atsushi Kawaguchi, St. Justine's Hospital

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Insufficiency	Device: NIOD Frequencer	Phase 2; Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Airway Clearance Using Non-Invasive Oscillating Device in Critically Ill Children
• Estimated Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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.	Device: NIOD Frequencer; 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	Device: NIOD Frequencer; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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). ]
2. 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)
3. EtCO2 and its waveform. [ Time Frame: Baseline: before the procedure, Comparison: two minutes from the beginning of the procedure ]
4. 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.
5. 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). ]
6. 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). ]
7. 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). ]
8. 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.
9. 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. ]
10. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Atsushi Kawaguchi; 5149124247; atsushi@ualberta.ca

Contact: Lucy Clayton

Sponsors and Collaborators

St. Justine's Hospital

MEDTEQ

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Atsushi Kawaguchi, Principal Investigator, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT03821389
• Other Study ID Numbers: 000
• First Posted: January 29, 2019
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atsushi Kawaguchi, St. Justine's Hospital:

Chest Physiotherapy; Non-invasive; Oscillation; Secretion

Additional relevant MeSH terms:

Respiratory Insufficiency; Pulmonary Valve Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases