Non Invasive Hemodynamic MonitoringHORSENCT06396884
Hemodynamic Optimization During Spinal Anesthesia in the Elderly
An observational study of Non Invasive Hemodynamic Monitoring and Proximal Femur Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Non Invasive Hemodynamic Monitoring, Proximal Femur Fracture, Fluid Therapy
- What is being tested?
- Oscillometric intermittent non-invasive blood pressure and ClearSight
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2024to 31 Dec 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Older adult
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.
Who may be able to join
- Patients with American Society of Anesthesiologists (ASA) physical status I-III, candidate for surgical intervention for femoral fracture under spinal anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study
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.
Read the detailed 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.
- Being tested
- Oscillometric intermittent non-invasive blood pressure, ClearSight
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillometric intermittent non-invasive blood pressureDevice
The hemodynamic management followed liberal fluid therapy, as determined by the attending anesthetist's discretion
ClearSightDevice
The hemodynamic management will be conducted in accordance to a goal-directed fluid therapy (GDFT) utilizing the Clearsight system monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: ClearSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10-15 days
Secondary outcomes (1)
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
Measured: 10-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start14 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Hemodynamic MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 146 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROSSANO RF FESTA, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396884
- Sponsor's protocol ID
- 5924
- Acronym
- HORSE
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34916049Moppett 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.
PubMed 25500940Lorente 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.
PubMed 35945605Brauer 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.
PubMed 19826027Kannegaard 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.
PubMed 20075035Longo 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.
PubMed 36554865Carpenter 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.
PubMed 1599111Salmasi 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.
PubMed 27792044Ahuja 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.
PubMed 31939844Giglio 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.
PubMed 37386648
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06396884
- Acronym / sponsor ID
- HORSE / 5924
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Device: Oscillometric intermittent non-invasive blood pressureElderly 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. |
| ClearSight Group | – | Device: ClearSightElderly 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 |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists (ASA) physical status I-III, candidate for surgical intervention for femoral fracture under spinal anesthesia.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillometric intermittent non-invasive blood pressureThe hemodynamic management followed liberal fluid therapy, as determined by the attending anesthetist's discretion | Device | Control Group |
| ClearSightThe hemodynamic management will be conducted in accordance to a goal-directed fluid therapy (GDFT) utilizing the Clearsight system monitoring. | Device | ClearSight Group |
Primary outcome
Duration of hospitalization
Time frame: 10-15 days
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
1 secondary outcome
Incidence of at least one postoperative complication
Time frame: 10-15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 34916049Jessen 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.
- Background: PubMed 25500940Moppett 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.
- Background: PubMed 35945605Lorente 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.
- Background: PubMed 19826027Brauer 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.
- Background: PubMed 20075035Kannegaard 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.
- Background: PubMed 36554865Longo 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.
- Background: PubMed 1599111Carpenter 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.
- Background: PubMed 27792044Salmasi 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.
- Background: PubMed 31939844Ahuja 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.
- Background: PubMed 37386648Giglio 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROSSANO RF FESTA, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Invasive Hemodynamic Monitoring and Proximal Femur Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ROSSANO RF FESTA, MD (+390630154507, rossano.festa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization (time frame: 10-15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06396884, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.