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Hemodynamic OptimizaTion in Sitting POsition Surgery Trial (HOTSPOT)

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

Tracking Information
First Submitted Date  ICMJE November 10, 2021
First Posted Date  ICMJE December 3, 2021
Last Update Posted Date March 18, 2022
Estimated Study Start Date  ICMJE April 1, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic OptimizaTion in Sitting POsition Surgery Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hemodynamic Instability
  • Blood Pressure, Low
  • Orthopedic Disorder
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2023
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05143632
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Sponsor  ICMJE Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP