Study using a painless heart monitoring device to maintain blood flow and oxygen levels in patients undergoing hip and leg surgery under spinal anesthesia which helps to reduce complications after surgery.

Hemodynamic optimization based on oxygen delivery index in lower limb orthopedic surgery under regional anesthesia. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102265

Enrollment

100

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S70-S79- Injuries to the hip and thigh

Interventions

Intervention1: Goal directed hemodynamic therapy using Non Invasive Cardiac output monitor: This is a monitoring-based intervention. A non-invasive cardiac output monitoring device with surface electr

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age 40 - 70yrs, 2 BMI between 25-35kg/m2. 3 Scheduled for lower limb orthopaedic surgeries under regional anaesthesia 4 ASA Physical Status II-III 5 regular heart rhythm.

Exclusion criteria

Exclusion criteria: 1 Emergency surgeries 2 Patient allergy to 6% hydroxyethyl starch 130/0.4 3 contraindications for inotropes like CAD Angina uncontrolled diabetes renal dysfunction and recent stroke

Design outcomes

Primary

Measure	Time frame
To compare the incidence of major postoperative complications between the GDHT and Control group in first 30 days after surgeryTimepoint: first 30 days after surgery	—

Secondary

Measure	Time frame
To compare the time to ambulate and length of hospital stay postoperatively between the two groups. Timepoint: First 30 days of surgery	—

Countries

India

Contacts

Public ContactDr Narmatha S

ESIC Medical College and Hospital KK Nagar Chennai 600078

gilang@rediffmail.com9884149429

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026