Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229938
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2023-08-14
Brief Title:
Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOOI
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| METC 2018009 | OTHER | Ethics Committee VUmc | None |