Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries

Pulmonary Complication Clinical Trial

Official title:

Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815888
• Other study ID #: 2022/1879
• Status: Completed
• Start date: February 15, 2023
• Est. completion date: December 23, 2023

Study information

• Verified date: December 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 23, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atelectasis, Postoperative
• Pulmonary Atelectasis
• Pulmonary Complication

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Up to 6 hours
Secondary	Postoperative pulmonary complications	Incidence of pulmonary complications such as respiratory failure, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome, pneumothorax, atelectasis, bronchospasm.	Up to Postoperative 7 days.
Secondary	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.	Up to 6 hours
Secondary	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.	Up to 6 hours
Secondary	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.	Up to 6 hours
Secondary	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).	Up to postoperative 1 hour