Hemodynamic Optimization During Spinal Anesthesia in the Elderly

NCT06396884 | Recruiting FDA Device

• 1 other identifier: 5924
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Invasive Hemodynamic Monitoring; Proximal Femur Fracture; Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of at least one postoperative complication

  10-15 days

Study Arms (2)

Control Group

Elderly patients over 65 years of age who underwent surgery for femoral fracture under spinal anesthesia. These patients underwent oscillometric intermittent (5 mins) noninvasive blood pressure monitoring during the surgical procedure and received intraoperative hemodynamic management based on a liberal fluid therapy protocol.

Device: Oscillometric intermittent non-invasive blood pressure

ClearSight Group

Elderly patients over 65 years of age who will undergo surgery for femoral fracture under spinal anesthesia. These patients will undergo continuous and non-invasive blood pressure monitoring using the ClearSight system, and fluid management according to a hemodynamic optimization protocol based on goal-directed fluid therapy

Device: ClearSight

Interventions

Oscillometric intermittent non-invasive blood pressure DEVICE

The hemodynamic management followed liberal fluid therapy, as determined by the attending anesthetist's discretion

Control Group

ClearSight DEVICE

The hemodynamic management will be conducted in accordance to a goal-directed fluid therapy (GDFT) utilizing the Clearsight system monitoring.

ClearSight Group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study aims to enroll 146 patients aged over 65 years, with ASA (American Society of Anesthesiologists) scores I-III, undergoing surgery for femoral fracture under spinal anesthesia. After obtaining informed consent, 73 patients from a prospectively enrolled cohort (ClearSight group) will be compared with 73 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 based on the same eligibility criteria.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Rossano Festa

Roma, 00168, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 34916049 BACKGROUND

• 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.

  PMID: 25500940 BACKGROUND

• 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.

  PMID: 35945605 BACKGROUND

• 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.

  PMID: 19826027 BACKGROUND

• 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.

  PMID: 20075035 BACKGROUND

• 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.

  PMID: 36554865 BACKGROUND

• 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.

  PMID: 1599111 BACKGROUND

• 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.

  PMID: 27792044 BACKGROUND

• 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.

  PMID: 31939844 BACKGROUND

• 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.

  PMID: 37386648 BACKGROUND

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• ROSSANO RF FESTA, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ROSSANO RF FESTA, MD

CONTACT

+390630154507; rossano.festa@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: May 14, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)