Clinical trial NCT05751707: VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion
Official title: The Role of HFCWO Via The Vest® Airway Clearance System in Addition to NIRT in the Treatment of Patient With Acute Respiratory Failure and Hypersecretion: Monocentric, Parallel Group, Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Acute-on-chronic Respiratory Failure
Airway Clearance Impairment
Keywords: Acute respiratory failure
NIRT
HFCWO
Airway hypersecretion
Non Invasive Ventilation
High Flow Nasal Cannulae
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric Parallel Group Controlled Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: The study aims to evaluates if the treatment with HFCWO Via The Vest® Airway Clearance System, in addition to standard care in critically ill patients admitted in the Respiratory Intensive Care Unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute respiratory failure (ARF) or acute on chronic respiratory failure (including patients having home oxygen therapy, HFNC, NIV) both hypercapnic ARF (PaCO2 \> 45 mmHg; PaO2/FiO2 \<300) or hypoxaemic (PaCO2 \<45 mmHg; PaO2/FiO2 \<300);
* Informed consent from patient or legal tutor;
* Accessory respiratory muscles use;
* Respiratory rate above 25 apm;
* Use of non invasive respiratory therapy (NIRT) NIV+/-HFNC or HFNC alone since RICU admission
* Kelly neurological index ≤ 3
* Excessive airway mucus secretion (clinical evaluation asking the patient to cough) and inability to efficiently remove secretions (evaluated with the Cough Peak Flow (CPF) measurement. A CPF under 270 Lpm is highly suggestive of inadequate cough which prevent the patient from adequately manage and remove airway secretions.
* Cough score \< 3: in the case of inability to perform CPF measurement due to poor patient collaboration, cough adequacy will be evaluated by a respiratory physiotherapy with a semiquantitative score ("Cough score") based on the measurement of sputum volume produced after coughing three times (1 point: less than 2 mL, 2 points: 2-6 mL, 3 points: more than 6 mL).

Exclusion Criteria:

* Patient unwillingness or incapability to provide informed consent
* Need for subcontinuous NIV(more than 20 hours per day)
* Kelly neurological index \>3
* Cardiac arrest
* Severe haemodynamic instability (more than two amines required);
* acute coronary syndrome;
* Psychomotor agitation unresponsive to analgo-sedation (RASS\> 1)
* Contraindications to HFCWO use: acute pneumothorax (even if chest drainage is not required ); severe chest wall deformities (pectus excavatum, pectus carinatum or pectus arcuatum); severe obesity (BMI \>40 kg/m2); pregnancy; thoracic or abdominal surgery in the six previous weeks
* Nasal swab positivity to Sars-CoV-2
* Need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus

Primary outcomes:
measure: Rate of patients undergoing bronchoscopy
timeFrame: From date of randomization until the date when the patients undergoes bronchoscopy becauase he/she is unable to spontaneously remove secretion assessed as worsening of gas exchange or of radiological appearance, whichever comes first, up to 30 days
Secondary outcomes:
measure: Days of non-invasive respiratory treatment (NIRT) duration
timeFrame: From date of randomization until the date when the patient no more requires NIRT because of improving gas exchange, assessed up to 30 days (days)
measure: Days of RICU (respiratory intensive care unit) stay
timeFrame: From date of randomization until the date when the patient is clinically stable to be discharged from RICU, assessed up to 30 days (days-weeks)
measure: Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation
timeFrame: From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days
measure: Number of patients who undergo endotracheal intubation for inability to manage secretions in patients without a "do not resuscitate" (DNR) indication and RICU mortality for DNR patients
timeFrame: From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days
measure: Sputum volume
timeFrame: 10 days
measure: Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT
timeFrame: 48 hours after HFCWO treatment starting
measure: Respiratory function tests 90 days after hospital discharge
timeFrame: 90 days after hospital discharge
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato
state: AR
Study officials:
References:
citation: Longhini F, Bruni A, Garofalo E, Ronco C, Gusmano A, Cammarota G, Pasin L, Frigerio P, Chiumello D, Navalesi P. Chest physiotherapy improves lung aeration in hypersecretive critically ill patients: a pilot randomized physiological study. Crit Care. 2020 Aug 3;24(1):479. doi: 10.1186/s13054-020-03198-6.
citation: Mahajan AK, Diette GB, Hatipoglu U, Bilderback A, Ridge A, Harris VW, Dalapathi V, Badlani S, Lewis S, Charbeneau JT, Naureckas ET, Krishnan JA. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120.
citation: Nicolini A, Cardini F, Landucci N, Lanata S, Ferrari-Bravo M, Barlascini C. Effectiveness of treatment with high-frequency chest wall oscillation in patients with bronchiectasis. BMC Pulm Med. 2013 Apr 4;13:21. doi: 10.1186/1471-2466-13-21.
citation: Celik M, Yayik AM, Kerget B, Kerget F, Doymus O, Aksakal A, Ozmen S, Aslan MH, Uzun Y. High-Frequency Chest Wall Oscillation in Patients with COVID-19: A Pilot Feasibility Study. Eurasian J Med. 2022 Jun;54(2):150-156. doi: 10.5152/eurasianjmed.2022.21048.
citation: Scala R, Naldi M, Maccari U. Early fiberoptic bronchoscopy during non-invasive ventilation in patients with decompensated chronic obstructive pulmonary disease due to community-acquired-pneumonia. Crit Care. 2010;14(2):R80. doi: 10.1186/cc8993. Epub 2010 Apr 29.
citation: Hall GJ, Gandevia B. Relationship of the loose cough sign to daily sputum volume. Observer variation in its detection. Br J Prev Soc Med. 1971 May;25(2):109-13. doi: 10.1136/jech.25.2.109. No abstract available.