An observational study in Atelectasis, Postoperative and Pulmonary Complication, sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Istanbul University · Observational
Living donor nephrectomy surgeries can be performed in lateral position with laparoscopic technique which necessitates pneumoperitoneum. Considering the position and the pneumoperitoneum, lungs can be affected macroscopically. In this study, it is aimed to observe whether lungs are affected by the aforementioned entities. The hypothesis is based on possible deterioration of the lungs due to the physical features of laparoscopic nephrectomy. Lung Ultrasound Score (LUS) will be used to evaluate the actual condition of lungs. Accordingly, one hemithorax is consisted of 6 different zones, and depending on the existence of vertical B lines (that refers to atelectasis and consolidation) each zone is scored 0 to 3. Higher scores reflect worse lung conditions that is associated with the severity of atelectasis. The LUS will be performed at three time points that are 5 minutes after intubation (T1), at the end of surgery and before extubation (T2), and at 30th minute in the postanesthesia care unit (T3). Primary outcome will be the difference between T1 and T3, secondary outcomes will include perioperative blood gas analyses, intraoperative mechanic ventilator parameters, intraoperative total amount of fluid given, postoperative pulmonary complications.
308 studies on the registry are indexed under Pulmonary Atelectasis; 79 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 76 observational studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Istanbul University is the lead sponsor of 507 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult living donor nephrectomy patients who are scheduled for laparascopic nephrectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques
Diagnostic Test: Lung Ultrasound Score
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
The comparison of T1LUS (After intubation lung ultrasound score) T2LUS (Preextubation Lung ultrasound score)
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.)
Time frame: Up to 6 hours
Postoperative pulmonary complications
Incidence of pulmonary complications such as respiratory failure, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome, pneumothorax, atelectasis, bronchospasm.
Time frame: Up to Postoperative 7 days.
Comparison of Postanesthesia care unit (PACU) Partial arterial oxygen pressure (PaO2) and Lung ultrasound score at 30 minutes after extubation
A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial oxygen pressure (mmHg) will be evaluated.
Time frame: Up to 6 hours
Comparison of Postanesthesia care unit (PACU) Partial arterial carbon dioxide pressure (PaCO2) and Lung ultrasound score at 30 minutes after extubation
A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial carbon dioxide pressure (mmHg) will be evaluated.
Time frame: Up to 6 hours
Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS)
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.
Time frame: Up to 6 hours
Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation
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).
Time frame: Up to postoperative 1 hour
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.