Our Trials

rs154038_pg1_9383-hpr

Prevention of Respiratory Insufficiency after Surgical Management

A pragmatic randomised controlled trial of continuous positive airway pressure (CPAP) to prevent respiratory complications and improve survival following major abdominal surgery

Methodology International, multi-centre randomised controlled trial with open study group allocation.
Duration 48 months (until October 2019)
Objectives To determine whether early postoperative continuous positive airway pressure (CPAP) reduces the incidence of subsequent respiratory complications and improves one- year survival following major intra-peritoneal surgery.
Benefit If CPAP is associated with an improvement in patient outcomes then it may be introduced as a standard of care for these patients improving overall morbidity and mortality rates, reducing hospital length of stay, freeing resources for use in other areas.
Number of patients 4800 patients
End points The primary outcome measure is a composite of pneumonia, re-intubation, or death within 30 days of randomisation.

Secondary outcomes

Postoperative infection, mechanical ventilation at 30 days

All cause mortality, Quality adjusted life years at 1 year

This is an observational study.

We will seek patient consent for participation. A Participant Information Sheet will be provided which will explain the reasons for data collection and give an overview of the data which will be collected and stored. Data will be stored in the PQIP Database which has already received a favourable REC/CAG opinion.

We anticipate a large number of hospitals participating, at least 70 in the first year, and we hope that this number will rise in years to come. This may pose some organisational challenges but both the Chief Investigator, and the organisation supporting this study (the National Institute for Academic Anaesthesia’s Health Services Research Centre based at the Royal College of Anaesthetists) have experience in running major multi-centre studies involving up to 200 Trusts, therefore we are confident that we have the administrative and organizational capacity to manage the study.

There is currently no national or comprehensive database which records postoperative complications on patients in the UK outside a few specific surgical complications (e.g. return to operating room) or procedures (e.g. nephrectomy).

 

This is an important omission as significant postoperative complications are up to 10 times more common than short-term mortality after surgery, and have been independently associated with reduced postoperative survival and quality of life. We currently have no way of measuring and therefore improving upon these important outcomes. We also know from the US, that there is wide variation in “failure to rescue” between different healthcare institutions – i.e. if a patient develops a postoperative complication, whether they die or not after this complication varies up to 15-fold between different healthcare providers. We do not have access to this type of information in the UK presently, and this study will provide these data.

 

PQIP will measure both objective outcomes (morbidity and mortality) and also outcome from the patient perspective after major surgery. The web-based data entry system will include the features which have been suggested by stakeholders to be important for facilitating the use of data for improvement, such as near-real time feedback, feedback provided in easily understandable and graphical formats, and explanations for statistical analyses and risk adjustment techniques.

Hospital intensive care units (ICUs) can be dangerous places. A year after being discharged, 70% of patients remain ‘functionally disabled’ due to their hospital stays. One reason for this is muscle wasting experienced in hospital.

We want to test a treatment called Repetitive Occlusion Stimulus (ROS). A fabric cuff, similar to that used to measure blood pressure, is placed round one thigh and inflated and deflated repeatedly, causing a restriction and then release of blood flow. This has been shown to effectively reduce muscle wasting in patients who are less ill but it has not been tried in ICU patients before.
We will take ultrasound measurements during patients’ stay in ICU, take blood tests and carry out strength tests.

Previous ICU patients and family members have identified this area of research as a priority.

The results will help us design a larger trial, with potential to definitively establish if ROS works. If it does, it has its impact could be substantial, at low cost.

The burden of the effects of acute muscle wasting is inexorably rising. This is due to an aging population and a growing number of elderly patients undergoing major surgery and requiring critical care . The association between critical illness and the development of muscle loss and consequence weakness is known as intensive care unit-acquired weakness (ICU-AW) and affects up to 25% of ICU patients who require mechanical ventilation for at least 7 days. The mechanisms are highly complex and incompletely understood. However, the implications for recovery and thereafter resumption of prior work and lifestyle are well recognised.

What is only recently gaining recognition is that acute muscle loss (myopenia) can occur after uncomplicated elective surgery: both cardiac and non-cardiac surgery. Shared pathophysiological mechanisms between post-operative myopenia and ICU-AW seem likely – including systemic inflammation and decreased muscular activity. Although the implications of post-operative myopenia are undetermined they are likely to be deleterious. The risk of delayed recovery from surgery due to muscle weakness is recognised in ‘Enhanced Recovery’ programmes that promote early mobilisation.

National audit data has shown that episodes of hypotension are very common (~90%) in hip fracture patients and, when severe (~30%), are associated with increased death rates, possibly related to decreased blood flow to the brain (causing delirium), heart (causing heart rhythm and pumping abnormalities), lungs (causing postoperative pulmonary complications) and kidneys (causing kidney injury) after surgery.

The aim of this study is to see whether reducing the amount of hypotension (number, severity and duration of
episodes) during anaesthesia for hip fracture surgery decreases the frequency of delirium, heart abnormalities and
kidney failure within five days after the operation. We will randomly allocate eligible participants into one of two groups. A
control group will receive standard care. The intervention group will have their blood pressure will be monitored and
treated more rigorously according to a predetermined protocol, which describes acceptable blood pressure limits and
treatment options involving intravenous fluids and drugs to increase blood pressure.
We will include all patients over the age of 70 with a single broken hip who are able to consent to participation,
requiring any type of hip fracture surgery. Validated assessment tools will be used to determine whether or not one or
more of the clinical outcomes we are interested in have occurred in the five days after surgery.
This is a pilot phase of this study, so that we can further refine the number of participants required in total and resolve
any problems with our intended methods; data from pilot participants will be included in the full study.

During surgery under general anaesthesia the anaesthetist routinely monitors a range of physiological variables including the oxygen saturation of arterial blood. The technology is called near-infrared spectroscopy or NIRS and there are several manufacturers who produce this equipment. Delirium can occur in up to 30% of patients after surgery and as well as being distressing for the patient and their relatives it is associated with worse outcomes. In some groups of patients the presence of low levels of oxygen in the brain has been associated with the incidence of postoperative delirium. We would like to use this NIRS technology in a group of patients undergoing surgery at our institution.

This is a pilot study that will inform the design of a larger study that will assess the utility of NIRS in preventing postoperative delirium.

The Cheetah Medical Starling SV device (‘the device’) is being tested as a novel treatment for patients with sepsis and refractory hypotension. This study will determine if assessing fluid responsiveness with the device can lead to less IV fluid being given and improve the outcome of patients with sepsis, compared with the usual standard of care. The ability to measure the heart function before giving IV fluid has proved to have good patient benefit, this study will support this practice.

Participants will be randomised in a 2:1 treatment to control group to receive either treatment using the Cheetah Medical Starling SV device (‘the device’) or the standard of care treatment.

Participants must be aged 18 and over, have a diagnosis of sepsis and refractory hypotension and be anticipating an ICU admission. Participants will be ineligible if they have been in hospital for more than 24 hours after arrival and if they suffer from any other significant medical history or require immediate surgery.

Participants may experience a rash at the site of the device sensors. Participants may also experience slight bruising around the skin where the needle is inserted into the vein for blood sampling.

Participants will be recruited in the Accident and Emergency department of the Royal Surrey County Hospital after their diagnosis. Participants should not expect any benefit from participating in the study. Participation in this study is voluntary, and the volunteer may choose to the leave the study at any time without any specific reason. Before the initiation of the study volunteers will be informed (verbally and in writing) of potential risks. Detailed information about all study procedures and the inconveniences these might pose on the volunteers will be explained. Informed consent will be obtained from all participants or their representative if they are unable to give consent themselves.

Pathogens causing acute respiratory infections (ARI) are among the most likely candidates to cause the next pandemic. We need to better understand why some people become much more ill than others when they have an ARI.

It is likely that individual risk factors affect the body’s response to ARI in different ways and this in turn can influence the severity of disease. Within broad risk groups it is currently not possible to predict which individuals are at increased risk of becoming severely ill. Consequently, there are no opportunities to tailor preventive and therapeutic interventions.

In people who become moderately or severely ill, there is an assumption that the body’s underlying response to disease is the same and hence that everyone will benefit equally from the same treatments. Increased insight into how different individuals respond to respiratory pathogens can allow us to better anticipate severity at individual patient levels. This in turn will enable us to formulate strategies for individualized treatment option to reduce disease severity, risk of complications and hospitalisations.

In this study we will recruit people attending primary and secondary care in order to capture people with mild to severe ARI. We will analyse samples to observe individual gene activity and we will compare samples from people with different risk factors for more severe disease. This will provide a detailed insight into how the body responds to infection and provide opportunities to understand the specific contributions of different risk factors.

©2018 Royal Surrey County Hospital

Log in with your credentials

Forgot your details?