NCT05916599

Brief Summary

Goal directed fluid therapy is a new standard surgical procedure which is successful in patients undergoing hip revision arthroplasty, There has been a reduction of postoperative complications, most importantly surgery with a decrease inbleeding, as well as in hospital and intensive care stays it is related. The aim of this study is to evaluate effectiveness of pulmonary ultrasound score and vena cava collapse index measurements in the patients undergoing hip surgery under spinal anesthesia and relation with peroperative fluid management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

May 3, 2023

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison of groups for change of vena cava inferior collapsibility index in 4 time frames

    vena cava inferior collapsibility index will be measured at 4 time frames by using ultrasound,changes over 20% will be considered as significant

    vena cava inferior collapsibility index measurements will be done in 4 time frames.1.just before spinal anesthesia, 2. at fifth minute of surgery ,3. at 15. minute of surgery, 4 immediatelyafter surgery

Secondary Outcomes (1)

  • comparison of groups for pulmonary edema

    measurements will be done in 4 time frames.1.just before spinal anesthesia, 2. at fifth minute of surgery ,3. at 15. minute of surgery, 4immediately after surgery

Study Arms (2)

Goal directed

The inferior vena cava collapse index IVC CI and lung ultrasound score (LUS) measurements and goal directed fluid therapy will be done.Patients in the group will be started with fluid replasment at an hourly rate of 2ml/kg/h and with ultrasound measurement the infused fluid will be evaluated and regulated.

Device: ultrasound

conventional

. Group applying zero balance liquid therapy to patients with conventional methods is planned. Crystalloid liquid infusion at a rate of 2ml/kg/hour will be administered to the patients in the group additional fluid replacement will be decided by monitoring bleeding and urinary output, zero balance is aimed at patients.

Interventions

a device which is used in intensive care units,

Goal directed

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing hip surgery under spinal anesthesia

You may qualify if:

  • Patients over the age of 65 who will undergo hip surgery
  • ASA I-II-III patients

You may not qualify if:

  • Patients under the age of 65
  • Patients with ASA IV-V
  • Patients with BMI\>above 35
  • Patients with an Lus score of 15 and above
  • Patients who have not undergone spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Education and Research Hospital

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary EdemaHip Fractures

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • zuhal çavuş, MD

    gaziosmanpasa TREH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zuhal Çavuş, MD

CONTACT

dondu moralar, prof MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of anesthesiology

Study Record Dates

First Submitted

May 3, 2023

First Posted

June 23, 2023

Study Start

January 3, 2023

Primary Completion

August 9, 2023

Study Completion

September 12, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations