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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05916599
Other study ID # 138
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 3, 2023
Est. completion date September 12, 2023

Study information

Verified date June 2023
Source Gaziosmanpasa Research and Education Hospital
Contact zuhal Çavus, MD
Phone 05326323166
Email zuhalcavus74@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Patients who will undergo hip surgery under spinal anesthesia using the closed envelope method it will be randomized and divided into 2 groups. 1.The inferior vena cava collapse index IVC CI and lung ultrasound score (LUS) measurements and goal directed fluid therapy will be done 2. Group applying zero balance liquid therapy to patients with conventional methods is planned. 1. 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. 2. 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. Both groups were treated with spinal anesthesia in the postoperative period 120. minute IVC CI and the LUS score value will be checked. If the CI is below 50% and the LUS score is below 15, fluid management will be considered as successful.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date September 12, 2023
Est. primary completion date August 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 110 Years
Eligibility Inclusion Criteria: - Patients over the age of 65 who will undergo hip surgery - ASA I-II-III patients Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasound
a device which is used in intensive care units,

Locations

Country Name City State
Turkey Gaziosmanpasa Education and Research Hospital Istanbul Gaziosmanpasa

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 comparison of groups for pulmonary edema detecting 12 parts of lung with ultrasound with a score of 1-36 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
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