Surgical Procedures, OperativePostConMonNCT04010058
Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward
A study testing LIDCO CNAP device in people with Surgical Procedures, Operative and Hemodynamic Instability, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedures, Operative, Hemodynamic Instability, Blood Pressure Disorders
- What is being tested?
- LIDCO CNAP device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2019to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital
Guildford, GU2 7XX
About this study
Official title: Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward: a Feasibility Study
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.
Read the 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.
- Being tested
- LIDCO CNAP device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIDCO CNAP deviceDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Number of suitable patients who provide consent and have the device sited / number of suitable patients who provide consent (%)
Measured: 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 (%)
Measured: 3 months
Secondary outcomes (18)
What proportion of patients have any recorded episodes of hypotension?
Endpoint: proportion of patients with hypotension Outcome 1: number of patients with SBP<90mmHg / total number of patients (%)
Measured: 3 months
What proportion of patients have any recorded episodes of hypotension? Just considering the time on the ward, after PACU
Endpoint: proportion of patients with hypotension Outcome: number of patients with SBP<90mmHg / total number of patients (%)
Measured: 3 months
In the PACU, considering those with at least one episode of SBP<90mmHg, how long are patients hypotensive for? (CNAP data)
Endpoint: duration of hypotension, sum of all episodes Outcome 1: minutes of hypotension Outcome 2: proportion of total time in PACU with hypotension
Measured: 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?
Duration of hypotension from CNAP, sum of all episodes (CNAP min) Episodes of hypotension with CNAP, total duration as sum of individual episode durations
Measured: 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?
Duration of hypotension from VitalPAC, sum of all episodes (VitalPACmin) Episodes of hypotension with VitalPAC, total duration as sum of individual episode durations
Measured: 3 months
On the ward, when there are discrete episodes of hypotension, what is the distribution of nominal stroke volume index?
nominal stroke volume index (nSVI) Outcome 1: Histogram of nSVI Outcome 2: Proportion of episodes of hypotension with an nSVI: low (<35ml/m2), normal (35-65ml/m2) and high (>65ml/m2)
Measured: 3 months
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?
systemic vascular resistance index (SVRI) Distribution of SVRI
Measured: 3 months
During an episode of hypotension, what intravenous fluids are given, at what prescribed rate?
Endpoint: observation of clinical care Outcome: which intravenous fluids, at what prescribed rate?
Measured: 3 months
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?
Endpoint: SBP and nSVI before and during/after IVFB (30 minutes after start) Outcome 1: Categorise episodes into the following: responders (≥15% increase in nSVI or ≥15% SBP) or non-responders (<15% increase in nSVI and SBP) Outcome 2: Display distribution of nSVI (low/normal/high) prior to IVFB between responders and non-responders.
Outcome 3: Compare % change in nSVI in response to IVFB between those with low nSVI (potentially more responsive) to normal/high nSVI.
Outcome 4: Compare SVV (%) measured before IVFB between responders and non-responders.
Measured: 3 months
What proportion of IVF boluses are associated with a significant improvement in haemodynamics?
Endpoint: Number of IVFB that are associated with haemodynamic benefit (≥15% increase in nSVI or ≥15% SBP) / Total number of IVFB
Measured: 3 months
Volume of IVF given that would not have been indicated by CNAP readings
Endpoint: Sum of individual IVF boluses given when both of the following conditions are met at the start of the IVF bolus:
- Prior IVF did not improve nSVI by ≥15%
- Stroke Volume Variation <5%
Measured: 3 months
What treatments were delivered intra-operatively and in PACU.
Endpoint: observation of clinical care Outcome: Receipt of intravenous fluids, blood products, vasopressor drugs, admission to critical care.
Measured: 3 months
What are the clinical outcomes? length of stay (LOS)
Clinical outcomes from medical records : length of stay (LOS)
Measured: 3 months
What are the clinical outcomes? critical care admission
Endpoint: Clinical outcomes from medical records: critical care admission (ICU LOS)
Measured: 3 months
What are the clinical outcomes? acute kidney injury
Endpoint: Clinical outcomes from medical records: acute kidney injury (from urine output and change in creatinine)
Measured: 3 months
What are the clinical outcomes? acute myocardial infarction
Endpoint: Clinical outcomes from medical records: acute myocardial infarction (EPCO definition)
Measured: 3 months
What are the clinical outcomes? incidence of blood transfusion
Endpoint: Clinical outcomes from medical records: incidence of blood transfusion
Measured: 3 months
What are the clinical outcomes? unplanned ICU admission
Endpoint: Clinical outcomes from medical records: unplanned ICU admission.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start2 Sep 2019
- Primary completion22 Nov 2019 (estimated)
- Study completion22 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study of the use of an approved device (CE-marked) in a cohort of postoperative patients.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010058
- Sponsor's protocol ID
- 19SURN268889
- Acronym
- PostConMon
- Status last verified
- Sep 2019
- First submitted
- 27 Jun 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33094826
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04010058
- Acronym / sponsor ID
- PostConMon / 19SURN268889
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 22 Nov 2019 (estimated)
- Study completion
- 22 Nov 2019 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This is a feasibility study of the use of an approved device (CE-marked) in a cohort of postoperative patients.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIDCO CNAP deviceThe 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. | Device | – |
Primary outcome
Feasibility
Time frame: 3 months
Number of suitable patients who provide consent and have the device sited / number of suitable patients who provide consent (%)
Acceptability
Time frame: 3 months
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 (%)
18 secondary outcomes
What proportion of patients have any recorded episodes of hypotension?
Time frame: 3 months
What proportion of patients have any recorded episodes of hypotension? Just considering the time on the ward, after PACU
Time frame: 3 months
In the PACU, considering those with at least one episode of SBP<90mmHg, how long are patients hypotensive for? (CNAP data)
Time frame: 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?
Time frame: 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?
Time frame: 3 months
On the ward, when there are discrete episodes of hypotension, what is the distribution of nominal stroke volume index?
Time frame: 3 months
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?
Time frame: 3 months
During an episode of hypotension, what intravenous fluids are given, at what prescribed rate?
Time frame: 3 months
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?
Time frame: 3 months
What proportion of IVF boluses are associated with a significant improvement in haemodynamics?
Time frame: 3 months
Volume of IVF given that would not have been indicated by CNAP readings
Time frame: 3 months
What treatments were delivered intra-operatively and in PACU.
Time frame: 3 months
What are the clinical outcomes? length of stay (LOS)
Time frame: 3 months
What are the clinical outcomes? critical care admission
Time frame: 3 months
What are the clinical outcomes? acute kidney injury
Time frame: 3 months
What are the clinical outcomes? acute myocardial infarction
Time frame: 3 months
What are the clinical outcomes? incidence of blood transfusion
Time frame: 3 months
What are the clinical outcomes? unplanned ICU admission
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Derived from this study: PubMed 33094826King 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIDCO CNAP device in people with Surgical Procedures, Operative and Hemodynamic Instability, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Creagh-Brown (01483402724, bencb@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.