None listed
Conditions
Brief summary
Abdominal surgery is the most common surgery in Australia with over 130,000 operations annually. Complications are unfortunately common following upper abdominal surgery (UAS) and the most common type of complication is a post-operative pulmonary complication (PPC) with a reported incidence of up to 60% depending on the underlying risk characteristics of the patient and the surgery type. The leading cause of in-hospital death following UAS during is sepsis with a primary infective source of pneumonia. Preventing PPC is a key component of physiotherapy practice. Systematic reviews support the use of non-invasive ventilation (NIV) to prevent respiratory complications following abdominal surgery. NIV may reduce PPC risk by half, with a further sub-group effect specifically preventing pneumonia. Mechanically driven air-flow is delivered during inspiration via a sealed facemask or nasal interface until a predetermined positive airway pressure is obtained. This positive lung pressure increases lung volumes, reverses airway collapse, and improves gas exchange following abdominal surgery. Despite evidence supporting NIV, uptake in hospitals is poor and is utilised in just 3% of patients. If NIV has been shown to be superior to usual care in the prevention of PPC following abdominal surgery, why is it that this therapy is not widely provided as standard care? It could be because the perceived risk/negatives outweigh the benefit and the requirement for a dedicated skilled health professional to apply, titrate, and to monitor the use of NIV outside ICU. Unfortunately, this is conjecture as there is a paucity of cost-benefit and risk analysis evidence for NIV and requires investigating in detail. High flow nasal prongs (HFNP) have recently replaced standard oxygen therapy as standard care for surgical patients admitted to ICU. HFNP deliver heated and humidified gas flow via nasal prongs at a prescribed amount of oxygen with an increased flow of air which can provide a constant low level of positive airway pressure. HFNP may increase lung volumes and recruit collapsed alveoli. it is possible that HFNP could be a viable prophylactic modality preventing PPC and may be a more feasible option compared to NIV. This remains unproven as all NIV clinical trials investigating its prophylactic properties have only compared it to standard oxygen therapy. This trial aims to detect whether there is a possible signal towards reduction in PPC with the use of intermittent NIV in addition to continuous HFNP oxygen therapy following high-risk elective UAS and to measure the feasibility of providing these interventions. These findings will assist in designing and conducting future multi-centre trials.
Interventions
Extubation post-surgery onto high flow nasal prongs (HFNP) which will have fraction of inspired oxygen (FiO2) titrated to achieve a peripheral oxygenation (SpO2) of between 92-96% unless otherwise specified by attending anaesthetist (i.e. severe COPD). Gas flow rate will be set at 50l/min and can be decreased to a minimum of 30l/min if the patient requires for tolerance. HFNP is to be provided continuously from end of surgery (Day 0) to 48 hours later (Day 2). The intervention group will get an additional single 30-minute Bi-Level Positive Airway Pressure Non-Invasive Ventilation (BiPAP-NIV) session within four hours of extubation by either the attending anaesthetist or the specialist surgical physiotherapist (Day 0) then twice daily, 30-minute sessions of BiPAP-NIV on Day 1 and Day 2 with a Physiotherapist. BiPAP NIV will be delivered via facemask by a VPAP Resmed machine. This will be carried out with patients either sitting up in bed with the head of bed raised between 45 – 90 degrees as tolerated or sitting out of bed in a high back chair. Expiratory positive airway pressure (EPAP) will be set at 10cmH20. Inspiratory positive airway pressure (IPAP) will be initially set at 15cmH20 and adjusted as required to achieve tidal volumes of at least 6-8mls/kg. Participants with BMI > 30 will have a starting EPAP set at 12cmH20 and a starting IPAP set at 16cmH20. The difference between IPAP and EPAP (known as pressure support ventilation (PSV)) will be a minimum of 4cmH20 and the maximum total pressure (PSV + EPAP) will be no greater than 25cmH20. If a participant is unable to tolerate the set pressures, reassurance will firstly be given to the participant and the following modifications will be taken in sequential order, until patient tolerance is achieved: 1. Reduce EPAP to 8cmH20 (set minimum) 2. Reduce IPAP to 12cmH20 (set minimum) in decrements of 1cmH20. If the participant remains unable to tolerate the therapy despite pressure titration and reassurance, cessation of NIV therapy will occur and will be reported. Pressure rise time will be set at the slowest speed (900ms) and the inspiratory trigger will be set at the minimum value. Inspired gases will be heated and humidified via the VPAP Resmed machine. Air-leaks will be managed by fitting the correct size mask carefully with focus on leaks around the nasogastric tube. Any air leak will be monitored and recorded. Fi02 will be titrated to achieve Sp02 >92-96% unless otherwise specified by the medical team (i.e. COPD). The patient will be continuously monitored by the treating physiotherapist for the duration of the therapy and again at 30-minutes post BiPAP-NIV. Pre-operative physiotherapy education session (Boden et al, ACTRN12613000664741.) and post-op early ambulation protocol (Boden et al,) will be provided as per the LIPPSMAck-POP trial intervention group (ACTRN12613000664741). One (1) 20-30 minute pre-operative education session delivered by a Physiotherapist at the standard outpatient Pre-Admission Clinic appointment. The education is to be provided within 6 weeks of the schedued operation date and will be performed in person, however, if this is not possible, the patient will be contacted by phone and provided with the education and training via telephone and the booklet sent via mail. The pre-operative physiotherapy session will consist of education on the prevention of post-operative pulmonary complications stressing the importance of early post-operative ambulation and the performance of self-directed deep breathing and coughing (DB&C) exercises immediately from waking from the operation. Patients will be informed that the further they walk and the more often they walk away from the bedside each day following their operation the better their chance of avoiding serious post-operative complications (chest infection or deep vein thrombosis). They will be informed that a Physiotherapist will see them on the first post-operative day and assist them out of bed to walk as far as possible. They will be told that they will be walking at a pace that gets them a bit breathless and will be familiarised with the 0-10 Borg scale Rating of Perceived Exertion (RPE). They will be told that each time they walk it should feel like a 3-4/10 in exertion. After the first post-operative day session with the Physiotherapist they will be encouraged strongly to walk or exercise by their bedside as often as they can by themselves or with the assistance of a nurse or carer. As it is frequently not possible to ambulate as early and as often as recommended, participants will be encouraged (during the pre-operative intervention) to perform self-directed breathing exercises to protect their lungs during this time in bed. They will be instructed to perform the DB&C exercises immediately from waking from the anaesthetic and then every hour during daytime waking hours until their first ambulation session, and then at any time when they are not ambulant. The physiotherapist will then coach each participant in at least three repetitions, and as many as required to master technique, of two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath stacking manoeuvres. Each breath is held for three to five seconds. Each set of 10 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over on the abdominal incision to support the wound and to encourage greater expiratory force. Participants will be encouraged to practice these exercises prior to their operation to develop familiarity. Each patient in the intervention group will be given an estimate of their likelihood of getting a PPC based on available pre-operative information (type of procedure proposed, booked post-operative admission to ICU, usual length of procedure, respiratory co-morbidity, self rated fitness levels, current smoker). Patients will be informed that aggressive early self directed DB & C exercises and ambulation is effective in reducing this known risk of a PPC. Participants will be provided with an accompanying education booklet outlining what was presented on prevention of PPC, post-operative physiotherapy, early ambulation, self directed DB&C (2 sets of 10 DB followed by 3 coughs every hour during daytime) and the expected recovery process. Post-operatively participants will be provided with a standardised physiotherapy assisted early mobilisation program and reminded to do the DB&C exercises as per the booklet provided. No further coached respiratory physiotherapy is provided. To reduce confounding variables no other pre- or post-operative respiratory physiotherapy will be provided.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults having elective open upper abdominal surgery and/or advanced hand-assisted laparoscopic abdominal surgery with a planned postsurgical admission to ICU, or those having elective open upper abdominal surgery and/or advanced hand-assisted laparoscopic abdominal surgery for post-surgical admission to the ward who are screened as being at high risk of a PPC using the Melbourne Risk Prediction Tool (Scholes et al 2007)
Exclusion criteria
Under 18 years of age, any absolute contraindications to BiPAP NIV in the period following surgery prior to the first NIV session, requiring oesophagectomy surgery, obstructive sleep apnoea requiring continuous positive airway pressure (CPAP) overnight, extreme claustrophobia and unable to tolerate a NIV facemask, unable to understand verbal instructions in English, do not have capacity to give consent themselves, a current hospital patient for a separate episode of care, requiring organ transplant,