Hemodynamic OptimizaTion in Sitting POsition Surgery Trial

NCT05143632 | Completed FDA Device

• 1 other identifier: HOTSPOT21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Blood Pressure, Low; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• TWA MAP < 65 mmhg (expressed in mmHg)

  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.

  Surgery time

Secondary Outcomes (3)

• Incidence of cerebral oxygen desaturation episode

  Surgery time

• Rate of severe hypotensive episodes (MAP <60 mmHg or <50 mmHg)

  Surgery time

• Time to event (in seconds)

  Surgery time

Other Outcomes (3)

• Quantity of vasopressors and/or fluids

  Surgery time

• Incidence of perioperative adverse cardiac events.

  30 postoperative days.

• Incidence of perioperative acute kidney injury.

  48 postoperative hours.

Study Arms (2)

Intermittent NIBP monitoring

NO INTERVENTION

Oscillometric intermittent (3 mins) noninvasive blood pressure monitoring

ClearSight

EXPERIMENTAL

Continuous non invasive hemodynamic monitoring

Device: ClearSight

Interventions

ClearSight DEVICE

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.

ClearSight

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-elective patients (acute trauma) and hemodynamically unstable patients
• vascular system pathologies
• pregnant women
• patient refusal to participate to the study

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico A. Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

• Vergari A, Frassanito L, Piersanti A, Vassalli F, Pitoni S, Ruggiero E, Nestorini R, Festa R, Bernardi G, Lombardo P, Caputo CT, Ciolli G, Rossi M. Continuous versus intermittent noninvasive blood pressure monitoring during beach chair position for shoulder surgery: A randomised controlled trial. Eur J Anaesthesiol. 2026 Feb 1;43(2):139-148. doi: 10.1097/EJA.0000000000002259. Epub 2025 Aug 22.

  PMID: 40855940 DERIVED

MeSH Terms

Conditions

Hypotension; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aggregate Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 3, 2021
• Study Start: July 28, 2022
• Primary Completion: July 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)