Ultrasound in Evaluation of Preoperative Fluid Management of Hip Fracture Surgery Patients

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05916599

Collaborator

(none)

Enrollment

Location

8.3

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Edema Hip Fractures	Device: ultrasound

Detailed 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.

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.
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Ultrasound on Peroperative Fluid Management in Patients Undergoing Hip Surgery Under Spinal Anesthesia

Actual Study Start Date :

Jan 3, 2023

Anticipated Primary Completion Date :

Aug 9, 2023

Anticipated Study Completion Date :

Sep 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 a device which is used in intensive care units,
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.

Arm

Intervention/Treatment

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

a device which is used in intensive care units,

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.

Outcome Measures

Primary Outcome Measures

comparison of groups for change of vena cava inferior collapsibility index in 4 time frames [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]
vena cava inferior collapsibility index will be measured at 4 time frames by using ultrasound,changes over 20% will be considered as significant

Secondary Outcome Measures

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]
detecting 12 parts of lung with ultrasound with a score of 1-36

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa Education and Research Hospital	Istanbul	Gaziosmanpaşa	Turkey	34255

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

Investigators

Principal Investigator: zuhal çavuş, MD, gaziosmanpasa TREH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Döndü Genc Moralar, head of anesthesiology, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT05916599

Other Study ID Numbers:

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hip Fractures

Study Results

No Results Posted as of Jun 23, 2023