Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

NCT ID: NCT06229938

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-11-25

Brief Summary

Prospective observational study, in which the primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.

This study aims to include 150 elderly patients aging 70 years or older undergoing scheduled major surgery. The passive leg raising test on 4 consecutive time points in the perioperative period.

Detailed Description

Rationale:

There is currently limited evidence available on the occurrence of perioperative hypovolemia in the elderly population, and whether this hypovolemic state is related to postoperative complications in these patients. More information regarding this relationship may be valuable in strategies aiming for a reduction in postoperative complications in the elderly. In particular, postoperative complications lead to long term morbidity, decrease quality of live, increase health care costs and are the most important factor of patient survival. Therefore, the present study aims to investigate how many elderly patients suffer from hypovolemia in the perioperative period, and how this relates to postoperative complications.

Objective:

The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.

Study design:

Open, prospective, observational study

Study population:

150 elderly patients aging 70 years or older undergoing scheduled major surgery.

Intervention:

Passive leg raising test on 4 consecutive time points in the perioperative period

Main study endpoints:

Relative number of patients that have a change in stroke volume of more than 10% upon a passive leg raising test.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

One of the investigators will visit the ward and will use the inflatable blood pressure cuff around the index finger of the right hand. The measurement will be performed while sitting and is continued for 5 minutes after lowering the head end of the bed and raising the lower end of the bed. As the bed functions electronical the change in movement occurs slowly and without any effort. Overall discomfort associated with these tests is regarded to as minimal. There are no benefits related to participation.

Conditions

Hypovolemia; Perioperative/Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly perioperative population

All patients included in the study (minimum 70 years of age on day of surgery)

Passive leg raise manoeuvre

Intervention Type: OTHER

Stroke volume measurements are performed with the Nexfin hemodynamic monitor and the volemic state measurement is based on the principle of the classic passive leg raise test. The Nexfin monitor (Nexfin CC, Edwards Life Sciences, the Netherlands) uses a small inflatable cuff around the index finger of the right hand, to measure the blood pressure, and uses a specific algorithm to calculate the stroke volume.

First a baseline measurement is performed during supine position while the patient is lying in bed. Next, the head end will be lowered until lying flat, and the legs will be passively raised until the lower end of the bed is 30 degrees elevated. The change in stroke volume following the passive leg raise test is used to assess fluid responsiveness. An increase of 10% indicates a fluid responsive status or hypovolemia.

Interventions

Passive leg raise manoeuvre

Stroke volume measurements are performed with the Nexfin hemodynamic monitor and the volemic state measurement is based on the principle of the classic passive leg raise test. The Nexfin monitor (Nexfin CC, Edwards Life Sciences, the Netherlands) uses a small inflatable cuff around the index finger of the right hand, to measure the blood pressure, and uses a specific algorithm to calculate the stroke volume.

First a baseline measurement is performed during supine position while the patient is lying in bed. Next, the head end will be lowered until lying flat, and the legs will be passively raised until the lower end of the bed is 30 degrees elevated. The change in stroke volume following the passive leg raise test is used to assess fluid responsiveness. An increase of 10% indicates a fluid responsive status or hypovolemia.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Age 70 years or older
• Scheduled for elective surgery
• Procedures with expected postoperative stay of at least two days

Exclusion Criteria

• Procedure in ambulatory practice
• Acute surgery
• Patients with current cardiac arrhythmias
• Symptoms of cardiovascular shock or decompensation at presentation
• Impossible to perform measurements due to patient characteristics
• Inability to comprehend patient information and consequences of the study

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Carolien SE Bulte

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolien Bulte, Phd

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

METC 2018.009

Identifier Type: OTHER

Identifier Source: secondary_id

ABR NL62141.029.17

Identifier Type: -

Identifier Source: org_study_id