Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT02977390
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .

Condition or Disease	Intervention/Treatment	Phase
Stroke Volume; Cardiovascular System; Fluid Therapy	Other: Passive leg raise	N/A

Detailed Description

The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Passive Leg Raise (PLR) The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml. Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees. Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.	Other: Passive leg raise; By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.

Outcome Measures

Primary Outcome Measures

1. Assess passive leg raise responsiveness in spontaneously breathing aged patients. [Within 1 minute of the intervention]

   Stroke volume changes in ml and as per cent change compared to baseline

Secondary Outcome Measures

1. Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia. [30 minutes]

   Post spinal bloodpressure per cent change or 30 mmHg decrease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 80 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients ≥80 years of age, undergoing elective urologic surgical procedure

Exclusion Criteria:

• age <80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Huddinge		Sweden	14186

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Sigridur Kalman, Professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sigridur Kalman, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02977390
• Other Study ID Numbers: ANE-HS 2013-06
• First Posted: Nov 30, 2016
• Last Update Posted: Dec 1, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Dec 1, 2016