Clinical trial NCT05528159: Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic Surgeries
Official title: Perioperative Lung Ultrasound Score (LUS) Changes in Robotic and Laparoscopic Urologic Surgeries: A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for semi-elective/elective robotic and laparoscopic urologic surgeries that require supine/trendelenburg

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.


Eligibility criteria: 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

Primary outcomes:
measure: LUS change between T3 and T1
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Delta T (T2-T1) and surgical duration relation
timeFrame: Up to 6 hours
measure: Perioperative PaO2 analysis and its relation to T3 LUS
timeFrame: Up to 6 hours
measure: Intergroup oxygenation difference
timeFrame: Up to 6 hours
measure: Perioperative PaCO2 analysis and its relation to T3 LUS
timeFrame: Up to 6 hours
measure: Intraoperative compliance change
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References: