Pilot randomised controlled trial (RCT) aiming to primarily evaluate feasibility, acceptability, and change in inspiratory muscle strength (maximum inspiratory pressure - MIP) in patients performing supervised inspiratory muscle training using an inspiratory muscle trainer (IMT) device while waiting in hospital to have urgent cardiac surgery.

The Prince Charles Hospital0 个研究点目标入组 60 人开始时间: 2022年8月23日最近更新: 2022年8月29日

适应症

试验速览

暂无简介。

•Adult patients who can provide written informed consent and are admitted to TPCH for urgent cardiac surgery with cardiopulmonary bypass (for this study defined as patients admitted to hospital following the diagnosis of their heart condition and considered not safe to be discharged home before their surgery). Participants will be included in this study if they are determined to be at higher risk of developing PPCs as per current evidence. This would include one or more of the following:
•Current or recent smoker – defined as any amount of smoking history within 1 year of study recruitment
•Diagnosed COPD – defined by medical documentation of COPD, and/or respiratory function tests, and/or current or long-term use of respiratory medications
•Age greater than or equal to 70 years
•BMI greater than or equal to 30 kg/m2
•Clinical Frailty Scale greater than or equal to 4
•Diabetes Mellitus on pharmacological treatment

•Exclusion criteria
•<18 years of age
•Unable to provide informed consent and/or unable to participate due to cognitive issues, intellectual disability or neurological impairment
•Emergency/salvage surgery or insufficient time to provide effective intervention (cardiac surgery within 48 hours of diagnosis, admission or recruitment)
•Patients discharged home prior to surgery
•Contraindications/precautions to IMT:
•oLarge emphysematous bullae
•oRecent or current pneumothorax
•oRecent lung anastomosis – within past 8 weeks
•oSevere osteoporosis with high risk of rib fractures
•oCurrent fractured or flail ribs
•oAcute/unstable angina
•oKnown perforated eardrum
•oHaemodynamic instability -new significant arrhythmias, alteration in BP requiring an alteration in vasoactive medication, Systolic BP > 180mmHg or <85, HR >130 or <50, and/or fluctuations in BP or HR causing symptoms, Acute/decompensated cardiac failure or severe/decompensated valvular disorders as determined by medical staff
•oSignificant pain affecting breathing capacity

发起方