- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965634
- Original Trial
Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management
Investigation of the Effectiveness of Lung Ultrasonography in the Management of Intraoperative Fluid Therapy, Prospective Observational Study
Adequate and balanced fluid resuscitation is one of the cornerstones of intraoperative patient management. Over-resuscitation leading to positive fluid balance is associated with increased postoperative mortality and morbidity.
Invasive and non-invasive technologies can be used for the adequacy of intraoperative fluid therapy.
Lung ultrasonography (LUS) is a safe and accurate bedside imaging method. LUS, which is frequently used in the diagnosis of postoperative hypoxemia, has also begun to be preferred for fluid management in intensive care units.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Korgün Ökmen, PhD.
- Phone Number: 05057081021
- Email: korgunokmen@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with surgery with laparotomy
Exclusion Criteria:
- Chronic obstructive pulmonary disease
- Passed lung operation
- Uncontrolled hypertension
- Acute or chronic kidney failure
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LUS
Time Frame: peroperative
|
Lung ultrasound score (LUS) Lung ultrasonography; Lung ultrasound score will be created by performing ultrasonography in 4 quadrants according to the previously defined protocol. 0 points indicated the presence of only A lines, less than 2 B lines
|
peroperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PVI
Time Frame: peroperative
|
Pulse variable index (PVI) will be measured by finger pulse oximetry with the MASİMO device.
|
peroperative
|
|
CVP
Time Frame: peroperative
|
Central venous pressure(CVP) Pressure values measured by a central venous catheter applied by jugular or subclavian route |
peroperative
|
|
postoperative pulmonary complication
Time Frame: postoperative 6th hour
|
hypoxia (partial oxygen pressure below 95 on pulse oximetry and 10% decrease from the initial value) atelectasis
|
postoperative 6th hour
|
|
biochemical data 1
Time Frame: postoperative 6th hour
|
glomerular filtration rate (GFR) values normal results range from 90 to 120 mL/min/1.73
m2.
|
postoperative 6th hour
|
|
biochemical data 2
Time Frame: postoperative 6th hour
|
Blood urea nitrogen value mg/dl
|
postoperative 6th hour
|
|
biochemical data 3
Time Frame: postoperative 6th hour
|
Blood creatinine value mmol/dl
|
postoperative 6th hour
|
|
Mechanical ventilation data 1
Time Frame: peroperative
|
End-Tidal Carbon Dioxide Pressure mm/hg The partial pressure of CO2 detected at the end of exhalation is between 35 and 45 mm Hg or 4.0 to 5.7 kPa.
|
peroperative
|
|
Mechanical ventilation data 2
Time Frame: peroperative
|
Peak inspiratory pressure Values Peak inspiratory pressure is the highest pressure applied to the lungs during inhalation and should be kept below 35 cmH2O.It is automatically measured by respirators.
|
peroperative
|
|
Mechanical ventilation data 3
Time Frame: peroperative
|
Tidal Volume value Tidal volume is the volume of gas moving into and out of the lungs with each breath.
Normal tidal volume is 6 to 8 mL/kg, regardless of age.
It is automatically measured by respirators.
|
peroperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BursaYIEAH-2021-6-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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