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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]

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

Acute Respiratory Failure

High-Frequency Chest Wall Oscillation (HFCWO)

Condition category

Condition code

Respiratory

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]

Treatment: Devices

Intervention code [2]

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]

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]

At baseline and then immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO

Secondary outcome [1]

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]

At baseline and immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO

Secondary outcome [2]

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]

At baseline and immediately after (T0), after 1 (T1) and 3 (T3) hours the application of the HFCWO

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/12/2015

Actual

1/12/2015

Date of last participant enrolment

Anticipated

Actual

12/08/2016

Date of last data collection

Anticipated

Actual

12/08/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Vercelli

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Federico Longhini, MD

Address [1]

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee Alessandria

Ethics committee address [1]

Via Venezia 16, 15121, Alessandria

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

10/07/2014

Approval date [1]

11/09/2014

Ethics approval number [1]

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

Dr Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

longhini.federico@gmailom

Contact person for public queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

[email protected]

Contact person for scientific queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Chest physiotherapy improves lung aeration in hypersecretive critically ill patients: A pilot randomized physiological study.	2020	https://dx.doi.org/10.1186/s13054-020-03198-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically