An implementation-effectiveness trial to evaluate physiotherapy guideline care in practice and determine whether a course of protocolised physiotherapy ventilator lung hyperinflation treatment, added to guideline care, is feasible, safe, cost-effective and improves patient-important outcomes for ICU patients with severe pneumonia requiring invasive mechanical ventilation.

Not Applicable

Not yet recruiting

• Conditions: pneumonia; Respiratory - Other respiratory disorders / diseases; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12624001130550
• Lead Sponsor: South Metropolitan Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-18
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

•ICU admission with diagnosis of pneumonia made by a medical practitioner.•Aged equal to or greater than 18 years•Intubated and mechanically ventilated, expected to remain so for equal to or greater than 24 hours, not planned for extubation this calendar day.•Evidence of consolidation or volume loss on CXR, CT scan or lung ultrasound.•Evidence of sputum on clinical assessment by a physiotherapist, e.g. auscultation, palpation, endotracheal suction, waveform analysis.

Exclusion Criteria

•Death imminent or the treating clinician believes that death during this hospital admission is inevitable.•Treating clinician believes that trial participation is not in the best interests of the patient.•Receiving invasive mechanical ventilation for greater than 5 days•Peak airway pressure greater than 35cmH20 consistently for greater than 2 hours •Progression to severe ARDS according to Berlin Criteria [32]•Requirement for extracorporeal membrane oxygenation•Severe bronchospasm•Undrained pneumothorax or bronchopleural fistula•Pulmonary haemorrhage•Lung transplantation or recent lung surgery with bronchial resection•Unable to communicate in English•Pregnancy•Underlying neurological or myopathic condition•Documented cognitive impairment•BMI greater than 35•Hospitalisation for greater than 7 days prior to ICU•Presence of active cancer or active use of chemotherapeutic agents or neutropenia•Unlikely to be available for 3-month follow-up (resides overseas)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Disability[WHODAS 2.0 Day 90 post randomisation.]