Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward
PostConMon
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
September 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2019
CompletedSeptember 24, 2019
September 1, 2019
3 months
June 27, 2019
September 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility
Number of suitable patients who provide consent and have the device sited / number of suitable patients who provide consent (%)
3 months
Acceptability
In those patients who have provided consent and had the monitor sited, how many tolerate the device and keep it on throughout the observation period (at least 12 hours) and provide useable data / number of suitable patients who provide consent and have the device sited (%)
3 months
Secondary Outcomes (18)
What proportion of patients have any recorded episodes of hypotension?
3 months
What proportion of patients have any recorded episodes of hypotension? Just considering the time on the ward, after PACU
3 months
In the PACU, considering those with at least one episode of SBP<90mmHg, how long are patients hypotensive for? (CNAP data)
3 months
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?
3 months
On the ward, considering those with at least one episode of SBP<90mmHg, when using data from VitalPAC, how long are patients hypotensive for?
3 months
- +13 more secondary outcomes
Interventions
The LiDCO CNAP device (referred to as CNAP in this document) provides continuous cardiac output non-invasively, without the requirement for an arterial catheter. It uses a dual finger cuff in addition to a standard arm cuff (familiar to everyone who's had their blood pressure checked) and it transforms infrared plethysmographic signals into continuous blood pressure information. It uses an algorithm to derive cardiac output-related parameters. In recognition of the potential difference between the derived values and any measured values, it refers to some of its values as 'nominal' values. It has been evaluated in a range of surgical populations8-11 a post-operative cohort12, and a haemodynamically unstable critical care population13. In a population of patients undergoing endoscopy there was increased detection of episodes of hypotension compared with standard measures.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Related Publications (1)
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.
PMID: 33094826DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 8, 2019
Study Start
September 2, 2019
Primary Completion
November 22, 2019
Study Completion
November 22, 2019
Last Updated
September 24, 2019
Record last verified: 2019-09