Hypotension Probability Index in Anesthesia

NCT03663270 | Completed

• 1 other identifier: 09/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the value of the Hypotension Probability Index in reducing intraoperative hypotension in patients with primary hip replacement. The measurement of the blood pressure was and is of great interest for the treating physician/anesthesiologist to optimize the peri- and postoperative patients outcome. The non-invasive measurement can scale the blood pressure but not from heartbeat-to-heartbeat, what results in a loss of information. The invasive measurement by a placed catheter in an artery shows the blood pressure with information about the pulse wave form, the ascending angle, and makes it possible to detect hemodynamic changes in a way the non-invasive blood pressure measurement is lacking. The additional informations of the monitoring and a

Conditions

Hip Disease; Hypotension; Surgery; Anesthesia

Keywords

goal directed management

Outcome Measures

Primary Outcomes (1)

• Episode of hypotension

  The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Probability Index compared to standard care can reduce the incidence of intraoperative hypotension in patients with hip-replacement. As primary endpoints frequency (n)/h, absolute and relative duration (t \[min\]/% of total anesthesia time) of intraoperative hypotension were defined for this study.

  up to 18 months

Secondary Outcomes (2)

• Changes of fluid management

  up to 18 months

• Changes of catecholamine management

  up to 18 months

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

HPI monitoring to predict hypotension

Device: Hypotension probability index (HPI)

Control arm

NO INTERVENTION

blinded HPI monitoring

Interventions

Hypotension probability index (HPI) DEVICE

The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing hip-replacement
• General anesthesia
• Age ≥ 18 years

You may not qualify if:

• Participation in another (interventional) study
• Pregnancy and nursing mothers
• Surgery without controlled ventilation
• ASA \> III
• Contraindication for invasive blood pressure monitoring
• Renal insufficiency KDIGO Stadium ≥ 2
• Coagulation disorder

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Michael Sander

Giessen, 35392, Germany

Location

Related Publications (1)

• Schneck E, Schulte D, Habig L, Ruhrmann S, Edinger F, Markmann M, Habicher M, Rickert M, Koch C, Sander M. Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial. J Clin Monit Comput. 2020 Dec;34(6):1149-1158. doi: 10.1007/s10877-019-00433-6. Epub 2019 Nov 29.

  PMID: 31784852 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Computer generated random list
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Model Details: Randomized two arm study with two groups

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 10, 2018
• Study Start: June 22, 2017
• Primary Completion: June 30, 2018
• Study Completion: October 30, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

DE (1)