Atelectasis, PostoperativeNCT05815888
Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries
An observational study of Atelectasis, Postoperative and Pulmonary Complication, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Postoperative, Pulmonary Complication
- What is being tested?
- Lung Ultrasound Score
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 23 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult living donor nephrectomy patients who are scheduled for laparascopic nephrectomy
Who may be able to join
- >18 years of age
- Kidney donors
- Nephrectomy for transplantation
- Laparoscopic surgery
Who cannot join
- Chronic obstructive pulmonary disease grade III-IV
- existing structural lung disease (eg. interstitial lung disease)
- Pulmonary hypertension (>25 mmHg)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul
About this study
Official title: Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries: A Prospective Observational Study
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
- Being tested
- Lung Ultrasound Score
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound ScoreDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Living donor nephrectomy patients | Patients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques Receives: Diagnostic Test: Lung Ultrasound Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Up to 6 hours
Secondary outcomes (5)
Postoperative pulmonary complications
Incidence of pulmonary complications such as respiratory failure, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome, pneumothorax, atelectasis, bronchospasm.
Measured: 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
A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial oxygen pressure (mmHg) will be evaluated.
Measured: 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
A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial carbon dioxide pressure (mmHg) will be evaluated.
Measured: Up to 6 hours
Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS)
In order to observe the relation between the crystalloid amount given (ml) and its relation to lungs' ultrasonographic condition, intraoperative total fluid amount given will be evaluated.
Measured: Up to 6 hours
Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation
To understand the effects of lateral position and pneumoperitoneum on the lungs in acute postoperative period, LUS measurement at T1 (5 minutes after intubation) and LUS measurement at T3 (30 minutes after extubation) will be compared. LUS score vary between 0 to 36 (0= worst, 36= best condition of the lungs).
Measured: Up to postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Feb 2023
- Primary completion15 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis, PostoperativeStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Sertaç Bingül, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815888
- Sponsor's protocol ID
- 2022/1879
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05815888
- Acronym / sponsor ID
- 2022/1879
- Conditions
- Atelectasis, Postoperative, Pulmonary Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 18 Apr 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living donor nephrectomy patients | – | Diagnostic Test: Lung Ultrasound ScorePatients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult living donor nephrectomy patients who are scheduled for laparascopic nephrectomy
Key inclusion criteria (4 listed)
- >18 years of age
- Kidney donors
- Nephrectomy for transplantation
- Laparoscopic surgery
Key exclusion criteria (3 listed)
- Chronic obstructive pulmonary disease grade III-IV
- existing structural lung disease (eg. interstitial lung disease)
- Pulmonary hypertension (>25 mmHg)
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 |
|---|---|---|
| Lung Ultrasound Scoreone 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 | Diagnostic test | Living donor nephrectomy patients |
Primary outcome
The comparison of T1LUS (After intubation lung ultrasound score) T2LUS (Preextubation Lung ultrasound score)
Time frame: Up to 6 hours
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.)
5 secondary outcomes
Postoperative pulmonary complications
Time frame: 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
Time frame: 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
Time frame: Up to 6 hours
Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS)
Time frame: Up to 6 hours
Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation
Time frame: Up to postoperative 1 hour
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 21 Aug 2024.
- Individual participant dataSharing planned: No
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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, Postoperative and Pulmonary Complication, 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 3 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 21 Aug 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?
The comparison of T1LUS (After intubation lung ultrasound score) T2LUS (Preextubation Lung ultrasound score) (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?
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 21 Aug 2024.