Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management

May 13, 2025 updated by: Korgün Ökmen

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, we aimed to investigate the effectiveness of intraoperative LUS data in the control of fluid therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who will undergo open surgery in ASA I-III risk classes.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

  1. point indicated 1-2 B lines
  2. points indicated the presence of more than 3 well-spaced B lines;
  3. points indicated the presence of combined B lines
peroperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korgün Ökmen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BursaYIEAH-2021-6-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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