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Comparison of Time weighted average(TWI)spent by patients ,study group(using hypotensive predictive index algorithm moniter) and control group(using standard cardiac output moniter) to prevent hypotension while undergoing major abdominal surgeries

To compare hypotension predictive index and standard cardiac output monitoring in preventing hypotension in major abdominal surgeries - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068541
Enrollment
80
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: PCS- Health Condition 2: K958- Complications of other bariatric procedure Health Condition 3: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 4: K918- Other intraoperative and postprocedural complications and disorders of digestive system Health Condition 5: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: The study group (HPI guided group): • Hemodynamic management will be based on the hemodynamic parameters provided by the HemoSphere platform with the Acumen IQ sensor, including CI, SVV

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age of subject 18 years and above 2) Scheduled for elective major abdominal surgery. 3) ASA grade II – IV 4) Need for continuous invasive blood pressure monitoring.

Exclusion criteria

Exclusion criteria: 1)Patients with significant hypotension as measured before surgery. 2) patients with known left or right cardiac failure, known arrythmias (e.g., atrial fibrillation), cardiac shunts, severe aortic stenosis or the need for dialysis will be excluded. 3) If surgery included clamping of the aorta or Pringle’s manoeuvre, the patient is not eligible for the trial. 4) Finally, emergency procedures will also be excluded from the trial

Design outcomes

Primary

MeasureTime frame
determination of time weighted average(TWA) spent by the study group and control group in the trialTimepoint: Time weighted average will be calculated soon after the end of Anaesthesia for the specific surgery.

Secondary

MeasureTime frame
1) Determination of the incidence of intraoperative hypotension, i.e. the number of hypotensive events, total time (in minutes) spent with hypotension & the percentage of time spent in hypotension during surgery. 2) Determining the effect of hypotensive episodes & its duration & its effect on postoperative mortality (28 days) in form of myocardial ischemia, & acute kidney injury (AKI) as well as prolonged stay in ICU Timepoint: 1)KDIGO classification of AKI as SCr0.3 mg/dl from baseline within 48 hours, 1.5 times the baseline SCr within 7 days, or urine output less than 0.5 ml/kg/hr for more than 6 hours of urine output will be used to assess intraop and postop AKI occurrence. 2) ECG will be done pre op, post op at 24 hrs & 48 hrs respectively to detect any early changes of myocardial ischemia. 3) Pt/primary relative will be contacted telephonically to confirm about morbidity/mortality at 28 days postop.

Countries

India

Contacts

Public ContactDr Premlal Sreekumar
shaleen1974@rediffmail.com-7085870057

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026