Blood Pressure DeterminationNiMonNCT05496322
Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
A study testing Continuous Non Invasive Blood Pressure Monitoring and Intermittent Non Invasive Blood Pressure Monitoring in people with Blood Pressure Determination and Hemodynamic Monitoring, run by University of Messina at 1 site in Italy.
Trial summary
Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure Determination, Hemodynamic Monitoring, Postoperative Complications
- What is being tested?
- Continuous Non Invasive Blood Pressure Monitoring and Intermittent Non Invasive Blood Pressure Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,267 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2023to 1 Jul 2025
- 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
- All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
- Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.
Who cannot join
- Missing of preoperative serum creatinine during 30 days prior surgery
- Preoperative dialysis
- Chronic kidney disease (eGFR < 60ml/min Cockcroft-Gault equation)
- Surgical procedure lasting less than 60 min
- Planned use of permissive hypotension
- Urological procedures (including nephrectomy and renal transplantation)
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question
- Being tested
- Continuous Non Invasive Blood Pressure Monitoring, Intermittent Non Invasive Blood Pressure Monitoring
- Keywords
- Volume clamp, Continuous non invasive blood pressure monitoring
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Non Invasive Blood Pressure MonitoringDevice
Continuous non-invasive arterial pressure monitoring
Intermittent Non Invasive Blood Pressure MonitoringDevice
Intermittent non-invasive arterial pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| cNIBP | Experimental | Continuous non invasive blood pressure monitor (Volume clamp) Receives: Device: Continuous Non Invasive Blood Pressure Monitoring |
| iNIBP | Active comparator | Intermittent Non Invasive Blood Pressure (Brachial Cuff) Receives: Device: Intermittent Non Invasive Blood Pressure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative myocardial injury
The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) >= 30 ng/L in the first post-operative week)
Measured: 1 week
Secondary outcomes (4)
Post operative Acute kidney injury
Proportions of postoperative AKI (Definition: increase in postoperative serum creatinine concentration during the first 7 postoperative days by more than 1.5-fold or greater than 0.3 mg/dl. Preoperative concentration was defined as the most recent recorded measurement within 30 days before the surgery)
Measured: 1 week
Post operative death
Death during postoperative hospital stay
Measured: 28 day after surgery
Events 30d post surgery
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Measured: 30 days after surgery
Events 90d post surgery
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start26 Jan 2023
- Primary completion1 Apr 2025
- Study completion1 Jul 2025
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 Blood Pressure DeterminationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Responsible party
- Principal investigator, Alberto Noto, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496322
- Sponsor's protocol ID
- 16-22
- Acronym
- NiMon
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Noto A, Chalkias A, Madotto F, Ball L, Bignami EG, Cecconi M, Guarracino F, Messina A, Morelli A, Princi P, Sanfilippo F, Scolletta S, Tritapepe L, Cortegiani A; SIAARTI Study Group. Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial. J Anesth Analg Crit Care. 2024 Feb 6;4(1):7. doi: 10.1186/s44158-024-00142-w.
PubMed 38321507
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
- ClinicalTrials.gov ID
- NCT05496322
- Acronym / sponsor ID
- NiMon / 16-22
- Keywords
- Volume clamp, Continuous non invasive blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,267 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 11 Aug 2022 (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.
Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cNIBP | Experimental | Device: Continuous Non Invasive Blood Pressure MonitoringContinuous non invasive blood pressure monitor (Volume clamp) |
| iNIBP | Active comparator | Device: Intermittent Non Invasive Blood Pressure MonitoringIntermittent Non Invasive Blood Pressure (Brachial Cuff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
- Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.
Key exclusion criteria (7 listed)
- Missing of preoperative serum creatinine during 30 days prior surgery
- Preoperative dialysis
- Chronic kidney disease (eGFR < 60ml/min Cockcroft-Gault equation)
- Surgical procedure lasting less than 60 min
- Planned use of permissive hypotension
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 |
|---|---|---|
| Continuous Non Invasive Blood Pressure MonitoringContinuous non-invasive arterial pressure monitoring | Device | cNIBP |
| Intermittent Non Invasive Blood Pressure MonitoringIntermittent non-invasive arterial pressure monitoring | Device | iNIBP |
Primary outcome
Post operative myocardial injury
Time frame: 1 week
The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) >= 30 ng/L in the first post-operative week)
4 secondary outcomes
Post operative Acute kidney injury
Time frame: 1 week
Post operative death
Time frame: 28 day after surgery
Events 30d post surgery
Time frame: 30 days after surgery
Events 90d post surgery
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 38321507Noto A, Chalkias A, Madotto F, Ball L, Bignami EG, Cecconi M, Guarracino F, Messina A, Morelli A, Princi P, Sanfilippo F, Scolletta S, Tritapepe L, Cortegiani A; SIAARTI Study Group. Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial. J Anesth Analg Crit Care. 2024 Feb 6;4(1):7. doi: 10.1186/s44158-024-00142-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Non Invasive Blood Pressure Monitoring and Intermittent Non Invasive Blood Pressure Monitoring in people with Blood Pressure Determination and Hemodynamic Monitoring, run by University of Messina at 1 site in Italy.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 10 Mar 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative myocardial injury (time frame: 1 week). 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 NCT05496322, 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 10 Mar 2026.