None listed
Conditions
Brief summary
With any major surgery, there are risks of complications such as lung infection or pneumonia. These risks may be greater if surgery is urgent, patients must wait in hospital, and have limited physical activity. We know that it is good to prepare physically for surgery and one way we are looking at is how best to do this with the lungs and breathing muscles. Researchers have studied breathing muscle strengthening exercises before elective surgery and know that improving strength helps prevent complications, however we need to know more about what happens in the short period of time while patients are waiting in hospital for urgent surgery. Exercising with and without specific devices may assist, however we are not sure whether this works, what is best, how much and how strong the training should be, and whether patients having surgery will want to do the training or enjoy it. In summary we want to know how to best prepare lungs before surgery in a short period of time, to know if higher-intensity exercise for the breathing muscles is better and to decide whether we could use this routinely on patients who would require urgent surgery. This study is comparing 2 groups of participants having urgent open-heart surgery, to see if there is a difference in inspiratory (breathing in) muscle strength with training. This is called inspiratory muscle training (IMT). One group will do exercises with the breathing strengthening device and one will not. All participants in either intervention or control groups will receive usual pre-operative physiotherapy and other interventions that are currently provided. It is hypothesised that short term, high-intensity IMT is feasible, safe and acceptable with patients in hospital awaiting urgent cardiac surgery. It is also hypothesised that short term, higher-intensity IMT will give a clinically significant increase in maximum inspiratory breathing pressure (MIP) from baseline.
Interventions
The intervention is Inspiratory Muscle Training (IMT). This training is supervised by the research physiotherapist and is done with participant in the intervention group at a mutually convenient time on the ward where the participant is located until surgery. IMT is done by inspiring against resistance from an IMT device. The device used in this study is an electronic Powerbreathe. This is a portable TGA approved device that provides resistance to inspiration that can be modified to suit individual people and training load. The research physiotherapists in this study have all had greater than 8 years clinical experience and are experienced in research and in IMT and no specific training is required. The research physiotherapist will supervise all IMT sessions and monitor safety by review of the medical record and observation chart, general observations, and monitoring of SpO2 and HR during and immediately after for 5 minutes post training using a portable oximeter. Blood pressure and respiratory rate will be measured pre and post training. Participants will be suitable for IMT if there is a minimum of 2 days training available pre-surgery and they therefore can receive a minimum of 4 training sessions. The participant’s Maximal Inspiratory Pressure (MIP) will be used to determine the appropriate training load. This is the highest inspiratory pressure generated by the participant as measured by the Powerbreathe. The research physiotherapist will prescribe a training intensity of at least 50% of MIP, and from there will titrate the highest tolerable intensity (up to maximum 80% of MIP) that allows the participant to just complete the 6th breath in a set of 6 breaths. The BORG rate of perceived exertion scale will be used to ensure intensity of training is sufficient. This will aim to be the equivalent of 14-16 on the BORG scale, and this scale will be measured at each session. The intensity will be increased by the research physiotherapist across the training period and across training sessions to ensure adequate training stimulus. Training will be performed twice daily on weekdays (morning and afternoon), with the research physiotherapist assisting the participant to perform 5 sets of 6 breaths each session. Weekend IMT will not be done due to potential poor performance with unsupervised sessions and limited physiotherapy staff. Between sets, participants are allowed a rest period as required, and there will be at least 4 hours between sessions. Each training session is expected to take approximately 20 minutes, and training will continue until the day of surgery. Training will occur no closer than 1 hour after a meal. Before and after each training session, participants will be asked to report any current symptoms of pain on a 0-10 scale, and other symptoms. The research physiotherapist will monitor for any adverse events and respond accordingly to ensure safety. The intervention group also receive usual care. Usual care is standard physiotherapy pre-operative education. This is what is normally delivered to all patients having cardiothoracic surgery at this hospital, and involves watching video education, an opportunity to ask questions and written information in a booklet. This is delivered generally between 12-24 hours prior to surgery. The booklet and video are standard resources used at TPCH. The booklet called "Your guide to Cardiac Surgery" , and the video education (available on hospital TV loop and TPCH website) were developed by TPCH staff prior to this study and are standard practice.
Sponsors
Study design
Eligibility
Inclusion criteria
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
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: o Large emphysematous bullae o Recent or current pneumothorax o Recent lung anastomosis – within past 8 weeks o Severe osteoporosis with high risk of rib fractures o Current fractured or flail ribs o Acute/unstable angina o Known perforated eardrum o Haemodynamic 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 o Significant pain affecting breathing capacity