Evaluation with electrical impedance tomography (EIT) of the application of a High-Frequency Chest Wall Oscillation device to clear airway secretions

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001257550
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Federico Longhini, MD
• 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.
• Date of first enrolment: 01/12/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001257550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Dr Federico Longhini

• Name: Dr Federico Longhini

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory - Other respiratory disorders / diseases

Impaired cough with tracheobronchial secretion retention;Acute Respiratory Failure;High-Frequency Chest Wall Oscillation (HFCWO);
Impaired cough with tracheobronchial secretion retention
Acute Respiratory Failure
High-Frequency Chest Wall Oscillation (HFCWO)

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

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

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

Secondary ID(s)

None

Source(s) of Monetary Support

Federico Longhini, MD

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Committee Alessandria