Intraoperative Fluid ManagementNCT06965634
Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management
An observational study of Intraoperative Fluid Management, run by Korgün Ökmen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraoperative Fluid Management
- What is being tested?
- Lung ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo open surgery in ASA I-III risk classes.
Who may be able to join
- Patients with surgery with laparotomy
Who cannot join
- Chronic obstructive pulmonary disease
- Passed lung operation
- Uncontrolled hypertension
- Acute or chronic kidney failure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
In this study, we aimed to investigate the effectiveness of intraoperative LUS data in the control of fluid therapy.
- Conditions
- Intraoperative Fluid Management
- Being tested
- Lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDevice
Also called Lung ultrasound score
Lung ultrasonography ; lung ultrasonography will be applied in 4 quadrants according to the LUS protocol and LUS score will be created.
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS
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
- point indicated 1-2 B lines
- points indicated the presence of more than 3 well-spaced B lines;
- points indicated the presence of combined B lines
Measured: peroperative
Secondary outcomes (9)
PVI
Pulse variable index (PVI) will be measured by finger pulse oximetry with the MASİMO device.
Measured: peroperative
CVP
Central venous pressure(CVP)
Pressure values measured by a central venous catheter applied by jugular or subclavian route
Measured: peroperative
postoperative pulmonary complication
hypoxia (partial oxygen pressure below 95 on pulse oximetry and 10% decrease from the initial value) atelectasis
Measured: postoperative 6th hour
biochemical data 1
glomerular filtration rate (GFR) values normal results range from 90 to 120 mL/min/1.73 m2.
Measured: postoperative 6th hour
biochemical data 2
Blood urea nitrogen value mg/dl
Measured: postoperative 6th hour
biochemical data 3
Blood creatinine value mmol/dl
Measured: postoperative 6th hour
Mechanical ventilation data 1
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.
Measured: peroperative
Mechanical ventilation data 2
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.
Measured: peroperative
Mechanical ventilation data 3
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.
Measured: peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start20 May 2025 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Fluid ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korgün Ökmen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965634
- Sponsor's protocol ID
- BursaYIEAH-2021-6-10
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Lung Ultrasonography in the Management of Intraoperative Fluid Therapy, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06965634
- Acronym / sponsor ID
- BursaYIEAH-2021-6-10
- Conditions
- Intraoperative Fluid Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Korgün ÖkmenOther government
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, we aimed to investigate the effectiveness of intraoperative LUS data in the control of fluid therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo open surgery in ASA I-III risk classes.
Key inclusion criteria (1 listed)
- Patients with surgery with laparotomy
Key exclusion criteria (4 listed)
- Chronic obstructive pulmonary disease
- Passed lung operation
- Uncontrolled hypertension
- Acute or chronic kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundAlso: Lung ultrasound scoreLung ultrasonography ; lung ultrasonography will be applied in 4 quadrants according to the LUS protocol and LUS score will be created. | Device | – |
Primary outcome
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
9 secondary outcomes
PVI
Time frame: peroperative
CVP
Time frame: peroperative
postoperative pulmonary complication
Time frame: postoperative 6th hour
biochemical data 1
Time frame: postoperative 6th hour
biochemical data 2
Time frame: postoperative 6th hour
biochemical data 3
Time frame: postoperative 6th hour
Mechanical ventilation data 1
Time frame: peroperative
Mechanical ventilation data 2
Time frame: peroperative
Mechanical ventilation data 3
Time frame: peroperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Related trials for Intraoperative Fluid Management
Enrolling by invitationPhase 4
Phenotype Guided Vasoactive Medication During Kidney Transplantation
Kidney Transplant, Fluid Management
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Recruiting
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy
Not yet recruiting
PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery
Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs)
Recruiting
Restrictive Fluid Management In Liver Transplantation (REFIL)
Liver Transplantation (LT), End-stage Liver Disease (ESLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Fluid Management, run by Korgün Ökmen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Korgün Ökmen, PhD. (05057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUS (time frame: peroperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.