Hemodynamic OptimizaTion in Sitting POsition Surgery Trial

NCT ID: NCT05143632

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2024-11-30

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.

Conditions

Hemodynamic Instability; Blood Pressure, Low; Orthopedic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intermittent NIBP monitoring

Oscillometric intermittent (3 mins) noninvasive blood pressure monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

ClearSight

Continuous non invasive hemodynamic monitoring

Group Type: EXPERIMENTAL

ClearSight

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

VERGARI ALESSANDRO

Aggregate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico A. Gemelli

Rome, , Italy

Countries

Italy

References

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. 2025 Aug 25. doi: 10.1097/EJA.0000000000002259. Online ahead of print.

Reference Type: DERIVED

PMID: 40855940 (View on PubMed)

Other Identifiers

HOTSPOT21

Identifier Type: -

Identifier Source: org_study_id