Hemodynamic OptimizaTion in Sitting POsition Surgery Trial (HOTSPOT)

• ClinicalTrials.gov Identifier: NCT05143632
• Recruitment Status: Not yet recruiting
• First Posted: December 3, 2021
• Last Update Posted: March 18, 2022
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Information provided by (Responsible Party): VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Tracking Information

• First Submitted Date: November 10, 2021
• First Posted Date: December 3, 2021
• Last Update Posted Date: March 18, 2022
• Estimated Study Start Date: April 1, 2022
• Estimated Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2021)

TWA MAP < 65 mmhg (expressed in mmHg) [ Time Frame: Surgery time ]

The measure of hypotension will be expressed with the TWA-MAP value (time-weighted average intraoperative MAP) in mmHg to define the severity and duration of the hypotensive episode. The TWA MAP under a threshold of 65 mmHg will be calculated as the area between 65 mmHg threshold and the curve of the MAP measurements divided by total continuous reading time in minutes.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2021)

• Rate of severe hypotensive episodes (MAP <60 mmHg or <50 mmHg) [ Time Frame: Surgery time ]
  The number of severe hypotensive episodes (MAP <60 mmHg or <50 mmHg) recorded.
• Time to event (in seconds) [ Time Frame: Surgery time ]
  How long does it take for the medical staff to correct the hypotensive episode (in seconds).
• Quantity of vasopressors and/or fluids [ Time Frame: Surgery time ]
  Quantity of vasopressors (expressed in mg) and/or fluids (expressed in ml) used to correct the hypotensive events.
• Incidence of perioperative adverse cardiac events. [ Time Frame: 30 postoperative days. ]
  Major Adverse Cardiovascular Events - MACE - will be defined, according to the 3 points MACE, as a composite of non fatal stroke, non fatal myocardial infarction and cardiovascular death occurred within 30 postoperative days.
• Incidence of perioperative acute kidney injury. [ Time Frame: 48 postoperative hours. ]
  Acute Kidney Iniury - AKI - will be defined, according to the KDIGO criteria, as an increase in serum creatinine by greather than or equal to 0.3 mg/dL within 48 postoperative hours.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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. For a subgroup of patients, brain oximetry will be monitored using the ForeSight system to record episodes of cerebral desaturation. Secondary endpoints include: 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: 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Hemodynamic Instability
• Blood Pressure, Low
• Orthopedic Disorder

Intervention

Device: ClearSight

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.

Study Arms

• No Intervention: Intermittent NIBP monitoring
  Oscillometric intermittent (3 mins) noninvasive blood pressure monitoring
• Experimental: ClearSight
  Continuous non invasive hemodynamic monitoring
  Intervention: Device: ClearSight

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 21, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2023
• Estimated Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05143632
• Other Study ID Numbers: HOTSPOT21
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Verification Date: March 2022