Clinical trial NCT05143632: Hemodynamic OptimizaTion in Sitting POsition Surgery Trial
Official title: Continuous Non-invasive Blood Pressure Monitoring to Increase Hemodynamic Stability During Sitting Position Orthopedic Surgery: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Blood Pressure, Low
Orthopedic Disorder
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Intraoperative hypotension (MAP \<65 mmHg) in patients undergoing general anesthesia is a notable risk factor for the development of post-operative complications including acute kidney injury (AKI), myocardial injury, stroke and delirium, and is strongly associated with increased mortality. Moreover, the mean and systolic blood pressure values tend to undergo significant fluctuations with different positions assumed by the patient during surgery. Since severe hypotensive phenomena are connected with cerebral hypoperfusion and are associated with negative outcomes, close monitoring of blood pressure is necessary.

The primary endpoint of this study is to evaluate the number of hypotensive episodes, their quality and their duration in patients monitored with the oscillometric intermittent noninvasive blood pressure method compared to patients with continuous noninvasive monitoring using ClearSight during orthopedic surgery in sitting position performed under general anesthesia and with interscalene block. The measure of hypotension will be expressed (in mmHg) with the TWA-MAP value (time-weighted average intraoperative MAP) to define the severity and duration of the hypotensive episode. Secondary endpoints include: episodes of cerebral desaturation measured by brain oximetry, number of severe hypotensive episodes (MAP \<60 mmHg or \<50 mmHg) recorded; time to event: how long does it take for the medical staff to correct the hypotensive episode (treated according to the planned protocol); quantity of vasopressors and/or fluids used to correct the hypotensive event; incidence of perioperative adverse cardiac events and acute kidney injury.

The primary hypothesis is that continuous non-invasive monitoring using ClearSight reduces the incidence of intraoperative hypotensive events (defined by mean arterial pressure below a value of 65 mmHg for more than 1 minute) and the duration of the events themselves, leading to an improvement in patients' outcomes.

Detailed description: Intraoperative hypotension (MAP \<65 mmHg) in patients undergoing general anesthesia is a notable risk factor for the development of post-operative complications including acute kidney injury (AKI), myocardial injury, stroke and delirium, and is strongly associated with increased mortality. Moreover, the mean and systolic blood pressure values tend to undergo significant fluctuations with different positions assumed by the patient during surgery, decreasing in the transition from the supine position to the sitting position (beach chair position) typically used during surgery that involves the anatomical district of the shoulder or proximal humerus. Since severe hypotensive phenomena are connected with cerebral hypoperfusion and are associated with negative outcomes, close monitoring of blood pressure is necessary. The investigators have introduced in clinical practice the use of non-invasive ClearSight sensor (Edwards Lifesciences Corp, Irvine CA, USA), which uses the volume-clamp and Physiocal technologies to obtain continuously calibrated blood pressure values and hemodynamic parameters. The primary endpoint of this study is to evaluate the number of hypotensive episodes, their quality and their duration in patients monitored with the oscillometric intermittent noninvasive blood pressure method compared to patients with continuous noninvasive monitoring using ClearSight during orthopedic surgery in seated position performed under general anesthesia and with interscalene block. The measure of hypotension will be expressed with the TWA-MAP value (time-weighted average intraoperative MAP) to define the severity and duration of the hypotensive episode. For a subgroup of patients, brain oximetry will be monitored using the ForeSight system to record episodes of cerebral desaturation. Secondary endpoints include: the incidence of brain oxygen desaturation measured using the ForeSight system, number of severe hypotensive episodes (MAP \<60 mmHg or \<50 mmHg) recorded; time to event: how long does it take for the medical staff to correct the hypotensive episode (treated according to the planned protocol); quantity of vasopressors and/or fluids used to correct the hypotensive event; incidence of perioperative adverse cardiac events and acute kidney injury.

The primary hypothesis is that continuous non-invasive monitoring using ClearSight reduces the incidence of intraoperative hypotensive events (defined by mean arterial pressure below a value of 65 mmHg for more than 1 minute) and the duration of the events themselves, leading to an improvement in patients' outcomes.

Eligibility criteria: Inclusion Criteria:

1. patients candidate for elective orthopedic surgery in sitting position under general anesthesia + interscalene block

Exclusion Criteria:

1. non-elective patients (acute trauma) and hemodynamically unstable patients
2. vascular system pathologies
3. pregnant women
4. patient refusal to participate to the study

Primary outcomes:
measure: TWA MAP < 65 mmhg (expressed in mmHg)
timeFrame: Surgery time
Secondary outcomes:
measure: Incidence of cerebral oxygen desaturation episode
timeFrame: Surgery time
measure: Rate of severe hypotensive episodes (MAP <60 mmHg or <50 mmHg)
timeFrame: Surgery time
measure: Time to event (in seconds)
timeFrame: Surgery time
Other outcomes:
measure: Quantity of vasopressors and/or fluids
timeFrame: Surgery time
measure: Incidence of perioperative adverse cardiac events.
timeFrame: 30 postoperative days.
measure: Incidence of perioperative acute kidney injury.
timeFrame: 48 postoperative hours.
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli
Study officials:
References: