None listed
Conditions
Brief summary
This prospective single centre randomised, controlled, assessor-blinded study, will investigate the effects of intrapulmonary percussive ventilation (IPV) in non-ventilated patients admitted to intensive care unit (ICU) on their length of stay (LOS), oxygenation and pulmonary complications (mainly pulmonary atelectasis and consolidation) compared to standard chest physiotherapy (CPT). Patients admitted to intensive care unit, who are not ventilated, will be randomised to receive IPV treatment (intervention group) or standard CPT (control group) until discharge from physiotherapy. Outcomes in both the groups will include; number of days in ICU, changes in peripheral oxygen saturation and oxygen requirement pre and one hour post each IPV or CPT session, as well as chest x-rays scores before and after treatment. We hypothesise that participants who receive IPV intervention will have better outcomes compared to participants who receive standard chest physiotherapy.
Interventions
Intrapulmonary percussive ventilation(IPV):
Intrapulmonary percussive ventilation is a positive pressure device which delivers mini bursts of high frequency (170 to 230 breaths per minute) sub-tidal breaths which is superimposed on patients own breathing cycle. IPV is mainly used to promote secretion clearance, reverse or prevent pulmonary atelectasis and promote oxygenation. In this study IPV will be delivered by Metaneb device (Hill-ROM, USA). Physiotherapists will be involved in delivering IP
Intrapulmonary percussive ventilation(IPV): Intrapulmonary percussive ventilation is a positive pressure device which delivers mini bursts of high frequency (170 to 230 breaths per minute) sub-tidal breaths which is superimposed on patients own breathing cycle. IPV is mainly used to promote secretion clearance, reverse or prevent pulmonary atelectasis and promote oxygenation. In this study IPV will be delivered by Metaneb device (Hill-ROM, USA). Physiotherapists will be involved in delivering IPV intervention using this Metaneb device. Participants (admitted to Nepean hospital Intensive care unit) in the intervention group will receive IPV treatment for at least 10 to 30 minutes minutes twice daily. Treatment will be provided (by physiotherapist) twice daily with exception of additional treatment session(s) if there is a clinical need due to deterioration in patient condition or as requested by ICU medical team. This additional treatment session will be provided on an intention to treat basis only and reason for the additional treatment will be documented. Preferred patient position will be sitting up in a chair with feet and back supported or sitting up in bed (45 to 60 degrees head up) with hips and knees flexed 20-30 degrees, and back supported. A mouthpiece or mask interface will be used to deliver the treatment. Non-ventilated patients with tracheostomy will be connected via tracheostomy tube connector with tracheostomy and cuff will be partially deflated if tolerated by the participant. Metaneb device will deliver IPV with aerosol delivery (normal saline ~ 0.9% NaCl) via in-line nebuliser. Short rest will be given to the patients during the IPV sessions usually at every 2-3 minutes interval or as requested by the participant. Participant will be encouraged to use sputum clearance technique such as forced expiratory techniques (huffing and coughing) during the rest period or when there is a need to clear airway secretions. Parameters such as respiratory rate, heart rate and blood pressure and oxygen saturation will be continuously monitored during the treatment. This treatment will be delivered for the entire stay in ICU or when treatment will no longer required or indicated. The criteria to stop this intervention are; 1. Nil signs of respiratory distress 2. SpO2 more than or equal to 95% on room air (more than or equal to 24 hours) 3. Resolution of consolidation/collapse (atelectasis). Assessed by the medical team (blinded) 4. Dry and non productive cough. Assessed by the medical team (blinded) Treatment will be withdrawn in the following situation; 1. Participant refuses to continue 2. Hemodynamic instability leading to exclusion criteria 3. Acute deterioration leading to one or more exclusion criteria
Sponsors
Nepean Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age: adults greater than or equal to 16 years - FiO2 greater than or equal to 28% via mask or high flow nasal cannula or greater than or equal to 3 litres/minute via nasal cannula - Evidence of pulmonary atelectasis or consolidation (Confirmed by ICU clinician) - Patients with SpO2 less than or equal to 90% on room air (RA), respiratory rate (RR) greater than or equal to 25, accessory muscle use (with exception of chronic pulmonary or cardiac condition where a lower SpO2 range is acceptable by the medical team). - Evidence of sputum retention (based on cough assessment and auscultation findings)
Exclusion criteria
Intubated patients - Hypoxemia due to non-respiratory or non-reversible causes such as congestive cardiac failure, low haemoglobin levels, pulmonary hypertension, pulmonary embolism - Hemodynamic instability; Systolic BP less than or equal to 80 mm Hg, acute myocardial ischemia, ventricular arrhythmia - FiO2 greater than or equal to 70% - Pneumothorax (with or without ICC) - Post esophagectomy / pneumonectomy patients - Patients with facial fractures/injuries/surgeries - Frank haemoptysis - Uncooperative/agitated/confused patients (RASS greater than or equal to +2) - Drowsy/sedated/unresponsive patients (RASS less than or equal to - 2) - Pregnant women (pregnant patients in critical care are often not stable and effects of IPV in pregnant patients is unknown) - Aggressive patients (potential harm to staff members) - Patients with communication difficulties (NESB) - utilisation of interpreter services twice daily may not be feasible and can be expensive.
Outcome results
None listed