Predicting Post-Induction Hypotensio
Recruiting
- Conditions
- Post-induction hypotension, intra-operative hypotension, acute kidney injury, stroke, myocardial injury, mortality.
- Registration Number
- NL-OMON29121
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1100
Inclusion Criteria
18 years or older
- Planned for any type of elective surgery or for intubation/tracheostomy in the IC
Exclusion Criteria
-Any right-sided structural pathology or reduced function (Tapse <1.5cm)
-Severe cardiac arrhythmias (with high heart rate), including atrial fibrillation
-Abnormal anatomy of the fingers
- Emergency surgery
- Noninvasive blood pressure (with the finger cuff) or invasive blood pressure (with an arterial cannula) can not be measured
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of continuous noninvasive arterial pressure waveform signals with the ClearSight and clinical data to be used to predict the likelihood of derangement of physiologic parameters in awake patients before induction of anesthesia and to predict the occurrence of post-induction hypotension using machine learning.
- Secondary Outcome Measures
Name Time Method - Incidence of post induction hypotension (defined as MAP < 65 mmHg). <br>- Time spent in post induction hypotension (defined as MAP < 65 mmHg). <br>- Incidence of intra-operative hypotension (defined as MAP < 65 mmHg). <br>- Time spent in intra-operative hypotension (defined as MAP < 65 mmHg).<br>- Need for vasopressors<br>- Response effect of hypotension treatment protocol<br>- Individual patient outcomes during the first 30 days after induction