Clinical trial NCT04010058: Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward
Official title: Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Procedures, Operative
Hemodynamic Instability
Blood Pressure Disorders
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study of the use of an approved device (CE-marked) in a cohort of postoperative patients.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The patient's clinical care will not be altered apart from an the use of a non-invasive monitor for a short time, without any biological sample acquisition, or follow-up. This is low risk.

The device works through a complex pressure measurement in the fingers and by slightly squashing the fingers it can cause minor impairments to circulation. This represents a very small risk. To mitigate this risk the investigators will exclude patients with impaired circulation to the fingers and fingers will be monitored.

The approach is necessarily on the day of surgery and for many people this is an anxious time. The investigators have a lot of experience of approaching patients on the day of surgery for providing consent for observational studies - the investigators use caution and sensitivity. The investigators do not approach patients who the clinical team consider anxious or where there is significant pressure on time.

Detailed description: Enrolled patients will have the CNAP sited in the post-anaesthetic care unit (PACU) and it will stay on their arm until at least 12 hours have passed. The device will collect continuous heart rate, blood pressure, and nominal cardiac output; it also derives a range of values from these measurements. There is minimal risk attributable to the use of the CNAP device. These devices are already in routine clinical use in the UK in intensive care units, high-dependency units and operating theatres.

To reduce burden on the patient, no additional HR/BP monitor is required and whenever the usual care team would like to know the HR or BP these values will be displayed. The additional parameters (related to measurement of cardiac output) will not be shared with the clinical team - they will remain blinded to these data because otherwise there is the risk that they would use this additional information to alter clinical management.

Medical notes will be examined to provide information about demographics, physical characteristics (height, weight), and previous medical history - please see case report form (CRF, appendix 1) for more details.

There are no blood tests, or other acquisition of biological samples.

Eligibility criteria: Inclusion Criteria:

* Has capacity to provide informed consent
* Surgery: planned or unplanned; all types including gastrointestinal, urology, orthopaedics and gynaecological
* Due for an inpatient stay (i.e. not day case surgery) on either Frensham or Bramshott wards (staff will have had training with the device on these wards)
* Aged 18 years or over

Exclusion Criteria:

* Admission to intensive care unit ICU / high dependency unit HDU
* Declines consent to participate, or lack capacity to provide consent
* Impaired circulation of the hands: Raynaud's disease or severe peripheral vascular disease.

Primary outcomes:
measure: Feasibility
timeFrame: 3 months
measure: Acceptability
timeFrame: 3 months
Secondary outcomes:
measure: What proportion of patients have any recorded episodes of hypotension?
timeFrame: 3 months
measure: What proportion of patients have any recorded episodes of hypotension? Just considering the time on the ward, after PACU
timeFrame: 3 months
measure: In the PACU, considering those with at least one episode of SBP<90mmHg, how long are patients hypotensive for? (CNAP data)
timeFrame: 3 months
measure: On the ward, considering those with at least one episode of SBP<90mmHg, when using data from the CNAP, how long are patients hypotensive for?
timeFrame: 3 months
measure: On the ward, considering those with at least one episode of SBP<90mmHg, when using data from VitalPAC, how long are patients hypotensive for?
timeFrame: 3 months
measure: On the ward, when there are discrete episodes of hypotension, what is the distribution of nominal stroke volume index?
timeFrame: 3 months
measure: On the ward, when there are discrete episodes of hypotension, when paired with MAP and a notional RAP, what is the distribution of systemic vascular resistance index, SVRI?
timeFrame: 3 months
measure: During an episode of hypotension, what intravenous fluids are given, at what prescribed rate?
timeFrame: 3 months
measure: During episodes of hypotension treated with an intravenous fluid bolus (IVFB) what is the haemodynamic response? Is the response predictable using either baseline nSVI or SVV?
timeFrame: 3 months
measure: What proportion of IVF boluses are associated with a significant improvement in haemodynamics?
timeFrame: 3 months
measure: Volume of IVF given that would not have been indicated by CNAP readings
timeFrame: 3 months
measure: What treatments were delivered intra-operatively and in PACU.
timeFrame: 3 months
measure: What are the clinical outcomes? length of stay (LOS)
timeFrame: 3 months
measure: What are the clinical outcomes? critical care admission
timeFrame: 3 months
measure: What are the clinical outcomes? acute kidney injury
timeFrame: 3 months
measure: What are the clinical outcomes? acute myocardial infarction
timeFrame: 3 months
measure: What are the clinical outcomes? incidence of blood transfusion
timeFrame: 3 months
measure: What are the clinical outcomes? unplanned ICU admission
timeFrame: 3 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
Study officials:
References:
citation: King CE, Kermode A, Saxena G, Carvelli P, Edwards M, Creagh-Brown BC. Postoperative continuous non-invasive cardiac output monitoring on the ward: a feasibility study. J Clin Monit Comput. 2021 Dec;35(6):1349-1356. doi: 10.1007/s10877-020-00601-z. Epub 2020 Oct 22.