Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-26

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Blood Pressure Determination Hemodynamic Monitoring Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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cNIBP

Continuous non invasive blood pressure monitor (Volume clamp)

Group Type EXPERIMENTAL

Continuous Non Invasive Blood Pressure Monitoring

Intervention Type DEVICE

Continuous non-invasive arterial pressure monitoring

iNIBP

Intermittent Non Invasive Blood Pressure (Brachial Cuff)

Group Type ACTIVE_COMPARATOR

Intermittent Non Invasive Blood Pressure Monitoring

Intervention Type DEVICE

Intermittent non-invasive arterial pressure monitoring

Interventions

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Continuous Non Invasive Blood Pressure Monitoring

Continuous non-invasive arterial pressure monitoring

Intervention Type DEVICE

Intermittent Non Invasive Blood Pressure Monitoring

Intermittent non-invasive arterial pressure monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No