Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hemodynamic Stability
  • Hip Fractures
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 120 years
Gender
Both males and females

Description

Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial ...

Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute. Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %. 1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus. End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %. 2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia. 2.2. Secondary end point(s): A. Intraoperative adverse events: Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex) Other: Acute renal failure (ARF), vomiting (V) Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f) Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other. B.Postoperative adverse events (at 48 hours) Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex) Other: Acute renal failure (ARF), UTI (Infu), vomiting (V). Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq). Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb). 2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery

Tracking Information

NCT #
NCT03843970
Collaborators
Not Provided
Investigators
Principal Investigator: HERRERA ROSA, PhD General University Hospital of Valencia