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Trial registered on ANZCTR


Registration number
ACTRN12615001257550
Ethics application status
Approved
Date submitted
7/09/2015
Date registered
17/11/2015
Date last updated
26/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation with electrical impedance tomography (EIT) of the application of a High-Frequency Chest Wall Oscillation device to clear airway secretions
Scientific title
Physiological effects of the application of a High-Frequency Chest Wall Oscillation device assessed through electrical impedance tomography (EIT) in critically ill patients undergoing invasive mechanical ventilation.
Secondary ID [1] 287419 0
None
Universal Trial Number (UTN)
Trial acronym
VEST-EIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired cough with tracheobronchial secretion retention 296547 0
Acute Respiratory Failure 296548 0
High-Frequency Chest Wall Oscillation (HFCWO) 296549 0
Condition category
Condition code
Respiratory 296392 296392 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomized in four treatments arms:
1) patients without airway secretions (i.e. < 2 bronchoaspiration/hour) and with no application of a recruitment maneuver (RM);
2) patients without airway secretions (i.e. < 2 bronchoaspiration/hour) and with the application of a RM;
3) patients with airway secretions (i.e. > 2 bronchoaspiration/hour) and with no application of a RM and
4) patients with airway secretions (i.e. > 2 bronchoaspiration/hour) and with the application of a RM.

An EIT belt and a HFCWO inflatable belt will be applied on the chest. After setting the EIT machine to record, a baseline measurement will be recorded (Baseline),
Patients will thereafter undergo to a session of 10 minutes of HFCWO device application at 12 Hz, as usual clinical practice.
As soon as the treatment ends (T0), after 1 (T1) and 3 (T3) hours another EIT records will be taken. Each EIT recording will last 10 minutes.
Airway suctioning with a closed system will be performed for around 20 seconds at around 30 seconds from record start.
To patients randomized to receive a RM, the RM (30 cmH2O of positive airway pressure for 30 seconds) will be applied 1 minute and 30 seconds after the airway suctioning.
Intervention code [1] 292776 0
Treatment: Devices
Intervention code [2] 293101 0
Treatment: Other
Comparator / control treatment
Patients with (i.e. > 2 bronchoaspiration/hour) or without (i.e. < 2 bronchoaspiration/hour) airway secretion will undergo to a session of 10 minutes of HFCWO device application at 12 Hz, as usual clinical practice. An EIT belt and, therefore, a HFCWO inflatable belt will be applied on the chest. After setting the EIT machine to record, a baseline measurement will be recorded, Afterwards, the HFCWO treatment will run for 10 minutes. As soon as the treatment ends (T0), after 1 (T1) and 3 (T3) hours another EIT records will be taken. Closed suctioning, to clear secretions from the airways, will be done before each record. This group of patients will not receive a RM (RM- group)
Control group
Active

Outcomes
Primary outcome [1] 296036 0
To evaluate if the application of a HFCWO device will different influence the lung aeration (as assessed by the end-expiratory lung impedence through EIT) in relation to: 1) the presence or absence of airway secretions and 2) the application of a RM.
Timepoint [1] 296036 0
At baseline and then immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO
Secondary outcome [1] 317306 0
To evaluate if the application of a HFCWO device will different influence the tidal volume (as assessed by the tidal impedence variation through EIT) in relation to: 1) the presence or absence of airway secretions and 2) the application of a RM.
Timepoint [1] 317306 0
At baseline and immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO
Secondary outcome [2] 317307 0
To evaluate if the application of a HFCWO device will different influence the gas exchange (as assessed with arterial blood gases) in relation to: 1) the presence or absence of airway secretions and 2) the application of a RM.
Timepoint [2] 317307 0
At baseline and immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO
Secondary outcome [3] 317308 0
To evaluate if the application of a HFCWO device will different influence vital parameters (i.e. heart rate and blood pressure) in relation to: 1) the presence or absence of airway secretions and 2) the application of a RM.
Timepoint [3] 317308 0
At baseline and immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO

Eligibility
Key inclusion criteria
All the patients meeting the following criteria will be eligible for the study: 1) age equal or greater than 18 years; 2) presence of consciousness; 3) previous invasive mechanical ventilation > 48 hours.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if meeting one or more of the following criteria: 1) major cardiac arrhythmias or ischemia; 2) presence of pneumothorax or emphysema; 3) abdominal or esophageal or spinal surgery in the previous 72 hours; 4) acute spinal injuries; 5) presence of shock status; 6) cerebral hypertension; 7) presence of broncho-pleural fistula or pulmonary embolism; 8) chest trauma with rib cage injury; 9) recent (1 week) thoracic surgery; 10) presence of chest burns; 11) presence of hemoptysis; 12) pregnancy and 13) consent withdraw.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patient will be defined as a patient with or without airway secretion, according to the number of tracheal secretion required per hour (lower or greater than 2).
Therefore, the patient will be randomized to receive or not a recruitment maneuver.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence has been generated by an online software for random sequence generation. The sequence has been inserted in sealed opaque envelopes with a progressive numeration from 1 to 30. There are two groups of envelops, one for each group of patient according to the presence or not of airway secretions,
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A specific computation of the sample size is not feasible, since no previous studies regarding this topic have been done. However, we believe that a total of 60 patients, 15 for each group (presence or not of airway secretion and application or not of a RM), will be enough for this physiological study.
After data analysis, the normal distribution will be assessed by the Kolmogorov-Smirnov test. Data will be expressed as mean (standard deviation) or median [25-75 interquartile range], according to the normality test.
Data will be compared with Student t-test or Mann-Whitney U test or chi2 or Fisher’s exact test, as indicated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7146 0
Italy
State/province [1] 7146 0
Vercelli

Funding & Sponsors
Funding source category [1] 291990 0
Self funded/Unfunded
Name [1] 291990 0
Federico Longhini, MD
Address [1] 291990 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country [1] 291990 0
Italy
Primary sponsor type
Individual
Name
Federico Longhini, MD
Address
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country
Italy
Secondary sponsor category [1] 290654 0
None
Name [1] 290654 0
Address [1] 290654 0
Country [1] 290654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293483 0
Ethical Committee Alessandria
Ethics committee address [1] 293483 0
Via Venezia 16, 15121, Alessandria
Ethics committee country [1] 293483 0
Italy
Date submitted for ethics approval [1] 293483 0
10/07/2014
Approval date [1] 293483 0
11/09/2014
Ethics approval number [1] 293483 0
AslVC.Rian.14.03

Summary
Brief summary
Impaired cough with retention of tracheobronchial secretions is a common complication of neuromuscular disorders. Ineffective cough can lead to tracheotomy for the sole purpose of airway suctioning in patients with severe respiratory failure. Accordingly, intensive chest physical therapy, including cough assistance, is often prescribed to
enhance secretion clearance. Cough assistance is traditionally based on inspiratory volume increase and manual abdominal thrust and/or chest compression. Mechanically assisted cough devices can also be used for this purpose, with either an endotracheal artificial airway or a mask. These devices sequentially apply positive and negative (subatmospheric) pressure to the airway, creating a pressure gradient to promote a peak expiratory flow (PEF) sufficient to remove secretions from the large airways.
Several studies have demonstrated the effectiveness of mechanically assisted cough devices and, in some cases, superiority to manual techniques in achieving secretion clearance in both acute and chronic subjects with ineffective cough with shorter periods of treatment. As a result, these devices are being increasingly used, and their commercial
availability in Europe has risen concomitantly. The use of mechanically assisted cough devices has been proposed for ICU patients as a means to facilitate successful extubation. Recently a High-Frequency Chest Wall Oscillation (HFCWO) device (The Vest, 105, Hill Rom), has been introduce in our clinical use to clear secretions from small airways to large ones.
Nowadays, no studies have physiologically investigated the effects of the application of a HFCWO device in patients with or without need for secretion suctioning, with or without the association of a recruitment manoeuvre (RM).
We therefore aim to evaluate the different response to the application of HFWO in patients with or without presence of airway secretions and in relation to the random application or not of a RM (30 cmH2O of positive airways pressure for 30 seconds). We therefore will be able to describe the physiological differences in lung aeration, tidal volume, gas exchange and vital parameters of four groups of patients:
1) patients without airway secretions and with no application of a RM;
2) patients without airway secretions and with the application of a RM;
3) patients with airway secretions and with no application of a RM and
4) patients with airway secretions and with the application of a RM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60090 0
Dr Federico Longhini
Address 60090 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 60090 0
Italy
Phone 60090 0
+393475395967
Fax 60090 0
Email 60090 0
longhini.federico@gmailom
Contact person for public queries
Name 60091 0
Dr Federico Longhini
Address 60091 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 60091 0
Italy
Phone 60091 0
+393475395967
Fax 60091 0
Email 60091 0
longhini.federico@gmail.com
Contact person for scientific queries
Name 60092 0
Dr Federico Longhini
Address 60092 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 60092 0
Italy
Phone 60092 0
+393475395967
Fax 60092 0
Email 60092 0
longhini.federico@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary