Non-invasive and Continuous Detection of Arterial Hypotension Using Photoplethysmographic Signal During Induction of Anaesthesia: Proof of Concept
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Primary Endpoint
- Continuous measure of mean arterial pressure (MAP in mmHg)
Study Overview
Brief Summary
During general anaesthesia, intraoperative hypotension (IOH), defined as a mean arterial pressure (MAP) drop of more than 20%, is frequent with potential deleterious effects for patients. Pulse oximeter is mandatory in the operating room making photoplethysmographic (PPG) signal and parameters such as the relative dicrotic notch height (Dicpleth) or the perfusion index (PI) readily available. The purpose of this study is to investigate whether Dicpleth and PI could detect IOH during anaesthesia induction and follow their variations during vasopressor boluses.
Detailed Description
Main objective Haemodynamic stability is a major issue in the management of patients during general anaesthesia. Anaesthetic drugs induce rapid and deep systemic arterial blood pressure (ABP) drop which leads to intra operative hypotension (IOH) episodes. IOH can cause deleterious consequences such as myocardial infraction, cerebral hypoperfusion or acute kidney injury.
The major drawback of the oscillometric cuff is to measure ABP only at intermittent intervals. As ABP may vary quickly, especially during induction of anaesthesia, IOH should be detected in real time as even a short period of IOH may have deleterious consequences on vital organs.
Digital photoplethysmography (PPG) is a non-invasive signal produced by light absorption variations due to pulsatile blood volume variations. Indices derived from PPG signals have been used successfully to characterize cardiovascular state in patients.
Dicrotic notch height (Dicpleth), representing the relative height of the dicrotic wave compared to the maximum peak of the waveform, has been described as the amount of reflected wave, dependent of the vascular tone. Reduction in Dicpleth has been shown to be related to reduction of vascular tone due to vasodilator drugs such as salbutamol or glyceryl Trinitrate.
Perfusion Index (PI) represents the ratio of the pulsatile light absorption (i.e the amount of blood ejected at each systole) on the continuous absorption (corresponding to the non-pulsatile vessels, bones and soft tissues). PI has been described as a reliable tool for vascular tone assessment and monitoring
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients > 18 years, scheduled an elective interventional neuroradiology procedure requiring general anesthesia
- •oral agreement obtained from each patient before anesthesia
Exclusion Criteria
- •age <18 years
- •an emergency procedure
Outcomes
Primary Outcomes
Continuous measure of mean arterial pressure (MAP in mmHg)
Time Frame: Time Frame: duration of the interventional neuroradiology procedure: 1 day
We calculated the variation of MAP during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.
Continuous measure of SpO2 in % by photoplethysmography
Time Frame: Time Frame: duration of the interventional neuroradiology procedure: 1 day
We calculated variations of Dicpleth, and perfusion index (PI) during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.
Secondary Outcomes
No secondary outcomes reported
Investigators
Joaquim MATEO
MD
Hopital Lariboisière