Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05815888
Collaborator
(none)
30
1
6.2
4.8

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lung Ultrasound Score

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Perioperative Lung Ultrasound Scores (LUS) in Living Donor Nephrectomy Surgeries: A Prospective Observational Study
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Aug 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Living donor nephrectomy patients

Patients who are scheduled for donor nephrectomy, and who will be operated in lateral position using laparoscopic techniques

Diagnostic Test: Lung Ultrasound Score
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

Outcome Measures

Primary Outcome Measures

  1. The comparison of T1LUS (After intubation lung ultrasound score) T2LUS (Preextubation Lung ultrasound score) [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.)

Secondary Outcome Measures

  1. Postoperative pulmonary complications [Up to Postoperative 7 days.]

    Incidence of pulmonary complications such as respiratory failure, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome, pneumothorax, atelectasis, bronchospasm.

  2. Comparison of Postanesthesia care unit (PACU) Partial arterial oxygen pressure (PaO2) and Lung ultrasound score at 30 minutes after extubation [Up to 6 hours]

    A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial oxygen pressure (mmHg) will be evaluated.

  3. Comparison of Postanesthesia care unit (PACU) Partial arterial carbon dioxide pressure (PaCO2) and Lung ultrasound score at 30 minutes after extubation [Up to 6 hours]

    A blood gas analysis will be obtained in the 30th minute of postanesthesia care, and arterial partial carbon dioxide pressure (mmHg) will be evaluated.

  4. Comparison of total given fluid amount (milliliters) and preextubation lung ultrasound score (T2LUS) [Up to 6 hours]

    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.

  5. Comparison of Lung ultrasound scores (LUS) after intubation(T1) and 30th minute after (T3) extubation [Up to postoperative 1 hour]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 years of age

  • Kidney donors

  • Nephrectomy for transplantation

  • Laparoscopic surgery

Exclusion Criteria:
  • Chronic obstructive pulmonary disease grade III-IV

  • existing structural lung disease (eg. interstitial lung disease)

  • Pulmonary hypertension (>25 mmHg)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Istanbul Faculty of Medicine Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emre Sertaç Bingül, Medical Doctor, Lecturer, Istanbul University
ClinicalTrials.gov Identifier:
NCT05815888
Other Study ID Numbers:
  • 2022/1879
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023