- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05815888
Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries
Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries: A Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Emre S Bingul
- Phone Number: +905544248822
- Email: dremrebingul@gmail.com
Study Locations
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Istanbul, Turkey
- Istanbul University Istanbul Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years of age
- Kidney donors
- Nephrectomy for transplantation
- Laparoscopic surgery
Exclusion Criteria:
- Chronic obstructive pulmonary disease grade III-IV
- existing structural lung disease (eg. interstitial lung disease)
- Pulmonary hypertension (>25 mmHg)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Living donor nephrectomy patients
Patients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques
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one hemithorax is consisted of 6 scanning zones. Each of them are evaluated via ultrasonography in terms of presence of vertical B lines (<4 B lines: 1 point; >3 B lines or thick B lines: 2 points; marked disturbance in pleural line: 3 points). Higher scores reflect worse outcomes such as atelectasis and consolidation, and totally 12 zones are evaluated. Three different time points are defined for LUS: T1: 5 minutes after orotracheal intubation T2: At the end of surgery, before extubation T3: 30 minutes after extubation, in postanesthesia care unit. DeltaT= T2LUS-T1LUS Blood gas analysis will be evaluated hourly throughout the surgery |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The comparison of T1LUS (After intubation lung ultrasound score) T2LUS (Preextubation Lung ultrasound score)
Time Frame: Up to 6 hours
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In order to observe the change in lung ultrasound scores between presurgical and at the end of the surgery, T2LUS (Lung ultrasound score before extubation) and T1LUS (Lung ultrasound score 5 minutes after intubation) will be compared.
(A value of 0 points LUS is the best condition of the lung with no consolidation or atelectasis.
36 points refer to worst condition of the lungs with atelectasis in all the zones.)
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Up to 6 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pulmonary complications
Time Frame: Up to Postoperative 7 days.
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Incidence of pulmonary complications such as respiratory failure, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome, pneumothorax, atelectasis, bronchospasm.
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Up to Postoperative 7 days.
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Comparison of Postanesthesia care unit (PACU) Partial arterial oxygen pressure (PaO2) and Lung ultrasound score at 30 minutes after extubation
Time Frame: Up to 6 hours
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A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial oxygen pressure (mmHg) will be evaluated.
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Up to 6 hours
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Comparison of Postanesthesia care unit (PACU) Partial arterial carbon dioxide pressure (PaCO2) and Lung ultrasound score at 30 minutes after extubation
Time Frame: Up to 6 hours
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A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial carbon dioxide pressure (mmHg) will be evaluated.
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Up to 6 hours
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Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS)
Time Frame: Up to 6 hours
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In order to observe the relation between the crystalloid amount given (ml) and its relation to lungs' ultrasonographic condition, intraoperative total fluid amount given will be evaluated.
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Up to 6 hours
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Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation
Time Frame: Up to postoperative 1 hour
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To understand the effects of lateral position and pneumoperitoneum on the lungs in acute postoperative period, LUS measurement at T1 (5 minutes after intubation) and LUS measurement at T3 (30 minutes after extubation) will be compared.
LUS score vary between 0 to 36 (0= worst, 36= best condition of the lungs).
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Up to postoperative 1 hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/1879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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