Lung EdemaNCT05916599
Ultrasound in Evaluation of Preoperative Fluid Management of Hip Fracture Surgery Patients
An observational study of Lung Edema and Hip Fractures, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Edema, Hip Fractures
- What is being tested?
- ultrasound
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2023to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing hip surgery under spinal anesthesia
Who may be able to join
- Patients over the age of 65 who will undergo hip surgery
- ASA I-II-III patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
dondu moralar, prof MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Education and Research Hospital
Istanbul, Gaziosmanpaşa, 34255
döndü G Moralar, prof.MD, dondugencm@gmail.com
About this study
Official title: Evaluation of Ultrasound on Peroperative Fluid Management in Patients Undergoing Hip Surgery Under Spinal Anesthesia
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.
Read the 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.
- Conditions
- Lung Edema, Hip Fractures
- Being tested
- ultrasound
- Medical subject headings
- Pulmonary Edema, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
a device which is used in intensive care units,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ultrasound | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
comparison of groups for pulmonary edema
detecting 12 parts of lung with ultrasound with a score of 1-36
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start3 Jan 2023
- Primary completion9 Aug 2023 (estimated)
- Study completion12 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung EdemaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
- Investigators
- zuhal çavuş, MD, Principal investigator, gaziosmanpasa TREH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916599
- Sponsor's protocol ID
- 138
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound on Peroperative Fluid Management in Patients Undergoing Hip Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05916599
- Acronym / sponsor ID
- 138
- Conditions
- Lung Edema, Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 9 Aug 2023 (estimated)
- Study completion
- 12 Sep 2023 (estimated)
- First posted
- 23 Jun 2023 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal directed | – | Device: ultrasoundThe 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. |
| 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. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing hip surgery under spinal anesthesia
Key inclusion criteria (2 listed)
- Patients over the age of 65 who will undergo hip surgery
- ASA I-II-III patients
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ultrasounda device which is used in intensive care units, | Device | Goal directed |
Primary outcome
comparison of groups for change of vena cava inferior collapsibility index in 4 time frames
Time frame: 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
1 secondary outcome
comparison of groups for pulmonary edema
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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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. This study is not recruiting at the moment.
dondu moralar, prof MD contact
zuhal çavuş, MD principal investigator
gaziosmanpasa TREH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Edema and Hip Fractures, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zuhal Çavuş, MD (05326323166, zuhalcavus74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of groups for change of vena cava inferior collapsibility index in 4 time frames (time frame: 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). 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 23 Jun 2023.