Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic Surgeries

NCT05528159 | Completed

• 1 other identifier: 2022/1056
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic and laparoscopic surgeries are tend to cause lung atelectasis due to the insufflation of CO2 into abdomen. However, ultrasonographic measurement for this phenomenon and its clinical use is not well investigated. In this particular study, It is aimed to observe lung ultrasound score (LUS) changes in robotic and laparoscopic supine position surgeries such as prostatectomies and cystectomies. LUS is a pragmatic measurement method that calculates the degree of atelectasis and consolidation in the lungs. Both hemithoraxes are separated into 3 different segments with vertical lines (one between the parasternal line and anterior axillary line, one between the anterior and posterior axillary line, and one posterior to the posterior axillary line). These vertical segments are also divided into two with an horizontal line on the nipple. Lung ultrasonography is applied in all 12 zones for both lungs in the intercostal regions and a scoring system is used. Accordingly, pure A lines (transverse frequent lines) reflects normal lung tissue with no consolidation and scored as zero points (Also named "A"). If less than 4 B lines (vertical lines reflecting some degree of consolidation) is observed, it refers to 1 point (named "B1"). 4 or more B lines refers to 2 points (B2), and if wide and coalesced B lines or patchy pleural line is observed that refers to 3 points (C). All evaluations will be made in supine position. In this trial, LUS will be applied in three different time points: T1: 5 minutes after orotracheal intubation T2: At the end of surgery, before extubation (under deep anesthetic state) T3: 30 minutes after extubation, in postanesthesia care unit During the surgery and the postoperative care period standart monitorization and mechanical ventilation data will be gathered. Also intraoperative and postoperative blood gas analysis will be obtained to observe oxygenation changes. This study is planned as a prospective observational study and our hypothesis is that LUS scores would be lower in acute postoperative period with robotic and laparoscopic surgeries. Therefore primary outcome is the numeric change in T3 and T1. Secondarily, LUS scores will be evaluated between robotic group and laparoscopic group patients for all time points.

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

• LUS change between T3 and T1

  LUS will be evaluated at the start of the surgery right after intubation (T1) and 30 minutes after the extubation (T3). LUS refers to "lung ultrasound score" . Accordingly, one hemithorax is divided into 6 zones where the ultrasound probe is placed. If there is only A lines (no consolidation) observed, it is accepted as zero points. If there are three or less B lines (vertical lines that move with the respiration), it refers to 1 point. Four or more vertical B lines refer to 2 points, and lastly distinct visible atelectasis with converged B lines and disrupted pleura refer to 3 points. In total, ultrasonography is applied on 12 different zones, and sum of the points show the actual LUS. Less points mean lungs with better condition, and higher points reflect lungs with atelectasis and consolidation. Therefore a 36 points LUS indicates severely injured lungs.

  Up to 6 hours

Secondary Outcomes (5)

• Delta T (T2-T1) and surgical duration relation

  Up to 6 hours

• Perioperative PaO2 analysis and its relation to T3 LUS

  Up to 6 hours

• Intergroup oxygenation difference

  Up to 6 hours

• Perioperative PaCO2 analysis and its relation to T3 LUS

  Up to 6 hours

• Intraoperative compliance change

  Up to 6 hours

Study Arms (1)

Robotic and Laparoscopic Urologic Surgery Group

Patients scheduled for robotic/laparoscopic urologic surgeries that will be performed under supine and trendelenburg position

Procedure: Intraabdominal CO2 insufllation

Interventions

Intraabdominal CO2 insufllation PROCEDURE

Patients will receive intraabdominal CO2 insufflation and will be operated under trendelenburg position

Robotic and Laparoscopic Urologic Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for semi-elective/elective robotic and laparoscopic urologic surgeries that require supine/trendelenburg

You may qualify if:

• \>18 years
• Laparoscopic urologic surgeries
• Robotic urologic surgeries
• Surgeries under supine and trendelenburg position

You may not qualify if:

• Known lung disease
• Emergency surgeries
• Known cardiac failure
• Known pulmonary hypertension
• Patients receiving inhaled agents
• Patients requiring lateral position surgeries

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Vuran Yaz I, Bingul ES, Canbaz M, Aygun E, Sanli MO, Ozcan F, Savran Karadeniz M. Evaluation of perioperative lung ultrasound scores in robotic radical prostatectomy: prospective observational study. J Robot Surg. 2025 Mar 11;19(1):112. doi: 10.1007/s11701-025-02272-x.

  PMID: 40069409 DERIVED

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: Associate Professor

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: December 7, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

TU (1)