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

Atelectasis Clinical Trial

Official title:

Perioperative Lung Ultrasound Score (LUS) Changes in Robotic and Laparoscopic Urologic Surgeries: A Prospective Observational Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528159
• Other study ID #: 2022/1056
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Istanbul University
• Contact: Meltem Savran Karadeniz, Assoc. Prof.
• Phone: 009005334845563
• Email: mskaradeniz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 30, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years

• Laparoscopic urologic surgeries

• Robotic urologic surgeries

• Surgeries under supine and trendelenburg position

Exclusion Criteria:

• Known lung disease

• Emergency surgeries

• Known cardiac failure

• Known pulmonary hypertension

• Patients receiving inhaled agents

• Patients requiring lateral position surgeries

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Procedure:
• Intraabdominal CO2 insufllation
Patients will receive intraabdominal CO2 insufflation and will be operated under trendelenburg position

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delta T (T2-T1) and surgical duration relation	Intraoperative LUS change will be evaluated in relation to surgical duration. 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	Perioperative PaO2 analysis and its relation to T3 LUS	PaO2 values will be evaluated at T3 time point to observe its relation with LUS scores. 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	Intergroup oxygenation difference	T3 PaO2 values will be compared in laparoscopic and robotic surgery groups.	Up to 6 hours
Secondary	Perioperative PaCO2 analysis and its relation to T3 LUS	PaCO2 values will be evaluated at T3 time point to observe its relation with LUS scores. 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	Intraoperative compliance change	dynamic compliance change between T2 and T1.	Up to 6 hours