Back to resultsVICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion (VICOR2)
Primary Purpose
Acute Respiratory Failure, Acute-on-chronic Respiratory Failure, Airway Clearance Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute respiratory failure, NIRT, HFCWO, Airway hypersecretion, Non Invasive Ventilation, High Flow Nasal Cannulae
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
Sites / Locations
- Ospedale San DonatoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWO
NIV+/-HFNC and no HFCWO
HFNC & HFCWO
HFNC and no HFCWO
Arm Description
Patient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND High Frequency Chest Wall Oscillations
Patient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND NO High Frequency Chest Wall Oscillations
Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations
Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations
Outcomes
Primary Outcome Measures
Rate of patients undergoing bronchoscopy
Bronchoscopy is required when the patient is unable to spontaneously remove secretions despite physiokinesitherapy (Cough score < 3 and gas exchange deterioration during NIRT (PaO2/FiO2<200 or PaO2 <60 and/or PaCO2 increasement of 20%) and/or radiological worsening (development of lobar/multilobar/pulmonary atelectasis or pre-existing atelectasis worsening)
Secondary Outcome Measures
Days of non-invasive respiratory treatment (NIRT) duration
Evaluates if reduction of NIRT duration in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Days of RICU (respiratory intensive care unit) stay
Evaluates if reduction of duration of RICU stay in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation
Evaluates if reduction of need for Invasive mechanical ventilation in patients treated with HFCWO compared to patients treat only with NIRT, occurs
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
Sputum volume
Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT
Likert questionnaire scale will be used to assess this outcome
Respiratory function tests 90 days after hospital discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05751707
Brief Title
VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion
Acronym
VICOR2
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2022 (Actual)
Primary Completion Date
December 24, 2024 (Anticipated)
Study Completion Date
December 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raffaele Scala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric Parallel Group Controlled Randomized Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWO
Arm Type
Experimental
Arm Description
Patient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND High Frequency Chest Wall Oscillations
Arm Title
NIV+/-HFNC and no HFCWO
Arm Type
No Intervention
Arm Description
Patient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND NO High Frequency Chest Wall Oscillations
Arm Title
HFNC & HFCWO
Arm Type
Experimental
Arm Description
Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations
Arm Title
HFNC and no HFCWO
Arm Type
No Intervention
Arm Description
Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations
Intervention Type
Device
Intervention Name(s)
High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
Intervention Description
High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System is a clinical device which consists in a pump which generates high frequency oscillations and connected to a jacket worn by the patient, intended to facilitate airway secretions clearance by detaching them from the bronchial wall and moving them upwards in the bronchial system.
Primary Outcome Measure Information:
Title
Rate of patients undergoing bronchoscopy
Description
Bronchoscopy is required when the patient is unable to spontaneously remove secretions despite physiokinesitherapy (Cough score < 3 and gas exchange deterioration during NIRT (PaO2/FiO2<200 or PaO2 <60 and/or PaCO2 increasement of 20%) and/or radiological worsening (development of lobar/multilobar/pulmonary atelectasis or pre-existing atelectasis worsening)
Time Frame
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 Outcome Measure Information:
Title
Days of non-invasive respiratory treatment (NIRT) duration
Description
Evaluates if reduction of NIRT duration in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Time Frame
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)
Title
Days of RICU (respiratory intensive care unit) stay
Description
Evaluates if reduction of duration of RICU stay in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Time Frame
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)
Title
Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation
Description
Evaluates if reduction of need for Invasive mechanical ventilation in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Time Frame
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
Title
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
Time Frame
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
Title
Sputum volume
Time Frame
10 days
Title
Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT
Description
Likert questionnaire scale will be used to assess this outcome
Time Frame
48 hours after HFCWO treatment starting
Title
Respiratory function tests 90 days after hospital discharge
Time Frame
90 days after hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raffaele Scala, MD
Phone
0575-255216
Email
raffaele.scala@uslsudest.toscana.it
Facility Information:
Facility Name
Ospedale San Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Scala, MD
Email
raffele.scala@uslsudest.toscana.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32746877
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.
Results Reference
result
PubMed Identifier
21906390
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.
Results Reference
result
PubMed Identifier
23556995
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.
Results Reference
result
PubMed Identifier
35703523
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.
Results Reference
result
PubMed Identifier
20429929
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.
Results Reference
result
PubMed Identifier
5581051
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.
Results Reference
result
Learn more about this trial
VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion
We'll reach out to this number within 24 hrs