AtelectasisNCT05528159
Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic Surgeries
An observational study of Atelectasis, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- Intraabdominal CO2 insufllation
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for semi-elective/elective robotic and laparoscopic urologic surgeries that require supine/trendelenburg
Who may be able to join
- >18 years
- Laparoscopic urologic surgeries
- Robotic urologic surgeries
- Surgeries under supine and trendelenburg position
Who cannot join
- Known lung disease
- Emergency surgeries
- Known cardiac failure
- Known pulmonary hypertension
- Patients receiving inhaled agents
- Patients requiring lateral position surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Lung Ultrasound Score (LUS) Changes in Robotic and Laparoscopic Urologic Surgeries: A Prospective Observational Trial
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:
Read more
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
- Being tested
- Intraabdominal CO2 insufllation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraabdominal CO2 insufllationProcedure or surgery
Patients will receive intraabdominal CO2 insufflation and will be operated under trendelenburg position
| Study group | Role | What they receive |
|---|---|---|
| Robotic and Laparoscopic Urologic Surgery Group | Patients scheduled for robotic/laparoscopic urologic surgeries that will be performed under supine and trendelenburg position Receives: Procedure: Intraabdominal CO2 insufllation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 hours
Secondary outcomes (5)
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.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
Intergroup oxygenation difference
T3 PaO2 values will be compared in laparoscopic and robotic surgery groups.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
Intraoperative compliance change
dynamic compliance change between T2 and T1.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start7 Dec 2022
- Primary completion15 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528159
- Sponsor's protocol ID
- 2022/1056
- Status last verified
- Jul 2024
- First submitted
- 1 Sep 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40069409
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lung Ultrasound Score (LUS) Changes in Robotic and Laparoscopic Urologic Surgeries: A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05528159
- Acronym / sponsor ID
- 2022/1056
- Conditions
- Atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic and Laparoscopic Urologic Surgery Group | – | Procedure: Intraabdominal CO2 insufllationPatients scheduled for robotic/laparoscopic urologic surgeries that will be performed under supine and trendelenburg position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for semi-elective/elective robotic and laparoscopic urologic surgeries that require supine/trendelenburg
Key inclusion criteria (4 listed)
- >18 years
- Laparoscopic urologic surgeries
- Robotic urologic surgeries
- Surgeries under supine and trendelenburg position
Key exclusion criteria (6 listed)
- Known lung disease
- Emergency surgeries
- Known cardiac failure
- Known pulmonary hypertension
- Patients receiving inhaled agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraabdominal CO2 insufllationPatients will receive intraabdominal CO2 insufflation and will be operated under trendelenburg position | Procedure or surgery | Robotic and Laparoscopic Urologic Surgery Group |
Primary outcome
LUS change between T3 and T1
Time frame: Up to 6 hours
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.
5 secondary outcomes
Delta T (T2-T1) and surgical duration relation
Time frame: Up to 6 hours
Perioperative PaO2 analysis and its relation to T3 LUS
Time frame: Up to 6 hours
Intergroup oxygenation difference
Time frame: Up to 6 hours
Perioperative PaCO2 analysis and its relation to T3 LUS
Time frame: Up to 6 hours
Intraoperative compliance change
Time frame: Up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 40069409Vuran 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.
- Individual participant dataSharing planned: Undecided
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUS change between T3 and T1 (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.