Hemodynamic Optimization During Spinal Anesthesia in the Elderly

Fluid Therapy Clinical Trial

— HORSE  

Official title:

Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396884
• Other study ID #: 5924
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: ROSSANO RF FESTA, MD
• Phone: +390630154507
• Email: rossano.festa[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In elderly patients over 65 years of age, proximal femur fracture is the most common type of fracture, and surgical intervention is typically required for the majority of cases. Subarachnoid anesthesia is commonly used for this type of surgery. The objective of this study is to assess the efficacy of continuous non-invasive blood pressure and hemodynamic monitoring compared to traditional methods of blood pressure measurement in reducing the duration of hospitalization and the incidence of post-operative complications in elderly patients undergoing surgery for femur fracture under subarachnoid anesthesia.

Description:

The proximal femoral fracture is the most frequent fracture in elderly patients over 65 years old, often affected by multiple comorbidities. It is one of the main causes of hospitalization in this population and is associated with high mortality rates.

Surgical treatment is indicated for the majority of fractures, and spinal anesthesia is the most commonly used technique for this type of surgery.

Hypotension is a very common side effect after spinal anesthesia, with a reported incidence of 16%-33%, attributable to a reduction in systemic vascular resistance, cardiac output, or both mechanisms. Several studies have demonstrated the association between intraoperative hypotension, usually defined as a mean arterial pressure <65 mmHg, myocardial and renal organ damage, and 30-day mortality.

In clinical practice oscillometric, non-invasive blood pressure measurement (NIBP) is the first choice of blood pressure monitoring in the majority of low and moderate risk surgeries. This monitoring system is a non-invasive cuff around the upper arm (NIBP-arm), which allows for non-invasive detection of blood pressure values, usually every 5 minutes.

New continuous noninvasive devices to acquire instantaneous arterial blood pressure (ClearSight™, Edwards) may be more sensitive to detect procedural hypotension. Additionally, this system provides advanced hemodynamic parameters not available with traditional oscillometric methods of blood pressure measurement, supporting the anesthesiologist in proactive hemodynamic management of the patient.

Several systematic reviews have demonstrated the effectiveness of hemodynamic optimization protocols in reducing postoperative complications. Orthopedic surgical procedures, along with abdominal and neurosurgical procedures, are among those that benefit most from the adoption of an advanced hemodynamic monitoring system associated with a Goal-Directed Therapy (GDT) protocol.

One hundred forty-six patients, aged ≥ 65 years, with an American Society of Anaesthesiologists' (ASA) score I-III, undergoing surgical intervention due to femoral fracture and spinal anaesthesia will be enrolled. Seventy-three patients from a prospectively enrolled cohort (ClearSight group) will be compared with seventy-three patients from a retrospective cohort (Control Group) who underwent the same type of surgery under spinal anesthesia between May 2023 and December 2023 and were included according to the same eligibility criteria.

In the retrospectively enrolled patient cohort (control group), an intermittent non-invasive blood pressure monitoring system was used, and intraoperative hemodynamic anesthetic management was not standardized but left to the discretion of the attending anesthesiologist, consistently with the protocols of the operating unit.

In the prospectively enrolled patient cohort (Clearsight group), continuous non-invasive monitoring of arterial pressure will be conducted using the ClearSight system, allowing clinicians to implement Goal-Directed Fluid Therapy.

The purpose of this study is to evaluate the effectiveness of continuous non-invasive blood pressure and hemodynamic monitoring compared to traditional methods of blood pressure detection in reducing length of hospital stay and the percentage of post-operative complications in elderly patients undergoing surgery for femoral fracture under spinal anesthesia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: December 31, 2025
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

Patients with American Society of Anesthesiologists (ASA) physical status I-III, candidate for surgical intervention for femoral fracture under spinal anesthesia.

Exclusion Criteria:

• Severe valvular heart disease

• Heart failure (New York Heart Association - NYHA class = 3)

• Vascular system pathologies

• Allergy or hypersensitivity to local anesthetics

• Absolute contraindications to spinal anesthesia

• Patient refusal to participate to the study

Related Conditions & MeSH terms

• Femoral Fractures
• Fluid Therapy
• Proximal Femur Fracture

Intervention

Device:
• Oscillometric intermittent non-invasive blood pressure
The hemodynamic management followed liberal fluid therapy, as determined by the attending anesthetist's discretion
• ClearSight
The hemodynamic management will be conducted in accordance to a goal-directed fluid therapy (GDFT) utilizing the Clearsight system monitoring.

Locations

Country	Name	City	State
Italy	Rossano Festa	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, Ruetzler K, Turan A, Sessler DI. Associations of Intraoperative Radial Arterial Systolic, Diastolic, Mean, and Pulse Pressures with Myocardial and Acute Kidney Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2020 Feb;132(2):291-306. doi: 10.1097/ALN.0000000000003048. — View Citation

Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462. — View Citation

Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006. — View Citation

Giglio M, Biancofiore G, Corriero A, Romagnoli S, Tritapepe L, Brienza N, Puntillo F. Perioperative goal-directed therapy and postoperative complications in different kind of surgical procedures: an updated meta-analysis. J Anesth Analg Crit Care. 2021 Dec 15;1(1):26. doi: 10.1186/s44158-021-00026-3. — View Citation

Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13. — View Citation

Kannegaard PN, van der Mark S, Eiken P, Abrahamsen B. Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival. Age Ageing. 2010 Mar;39(2):203-9. doi: 10.1093/ageing/afp221. Epub 2010 Jan 14. — View Citation

Longo UG, Vigano M, de Girolamo L, Banfi G, Salvatore G, Denaro V. Epidemiology and Management of Proximal Femoral Fractures in Italy between 2001 and 2016 in Older Adults: Analysis of the National Discharge Registry. Int J Environ Res Public Health. 2022 Dec 17;19(24):16985. doi: 10.3390/ijerph192416985. — View Citation

Lorente JV, Reguant F, Arnau A, Borderas M, Prieto JC, Torrallardona J, Carrasco L, Solano P, Perez I, Farre C, Jimenez I, Ripolles-Melchor J, Monge MI, Bosch J. Effect of goal-directed haemodynamic therapy guided by non-invasive monitoring on perioperative complications in elderly hip fracture patients within an enhanced recovery pathway. Perioper Med (Lond). 2022 Aug 10;11(1):46. doi: 10.1186/s13741-022-00277-w. — View Citation

Moppett IK, Rowlands M, Mannings A, Moran CG, Wiles MD; NOTTS Investigators. LiDCO-based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: a randomized trial and systematic review. Br J Anaesth. 2015 Mar;114(3):444-59. doi: 10.1093/bja/aeu386. Epub 2014 Dec 11. — View Citation

Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospitalization	To compare the length of hospital stay among elderly patients undergoing surgery for femoral fractures under subarachnoid anesthesia, where continuous non-invasive blood pressure monitoring utilizing the ClearSight system is implemented along with a standardized protocol for hemodynamic optimization, with the duration of hospital stay observed in a retrospective cohort of patients undergoing similar surgery but with intermittent (every 5 minutes) non-invasive blood pressure monitoring not linked to a standardized protocol for hemodynamic optimization	10-15 days
Secondary	Incidence of at least one postoperative complication	To compare the incidence of at least one of the following postoperative complications: pneumonia, pulmonary edema, ARDS (acute respiratory distress syndrome), pulmonary embolism, deep vein thrombosis, myocardial infarction, arrythmias, AKI (acute kidney injury), surgical site infection, wound dehiscence, urinary tract infection, sepsis, paralytic ileus, diarrhea, acute cerebrovascular accidents, delirium	10-15 days