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

NCT05815888 | Completed

• 1 other identifier: 2022/1879
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atelectasis, Postoperative; Pulmonary Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pulmonary complications

  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

  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

  Up to 6 hours

• Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS)

  Up to 6 hours

• Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation

  Up to postoperative 1 hour

Study Arms (1)

Living donor nephrectomy patients

Patients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques

Diagnostic Test: Lung Ultrasound Score

Interventions

Lung Ultrasound Score DIAGNOSTIC_TEST

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

Living donor nephrectomy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult living donor nephrectomy patients who are scheduled for laparascopic nephrectomy

You may qualify if:

• \>18 years of age
• Kidney donors
• Nephrectomy for transplantation
• Laparoscopic surgery

You may not qualify if:

• Chronic obstructive pulmonary disease grade III-IV
• existing structural lung disease (eg. interstitial lung disease)
• Pulmonary hypertension (\>25 mmHg)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Lecturer

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: April 18, 2023
• Study Start: February 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 23, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)