None listed
Conditions
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.
Interventions
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 E
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.
Sponsors
Federico Longhini, MD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed