Ultrasound Assessment of Extravascular Lung Water in Patients Undergoing Percutaneous Nephrolithotomy

April 14, 2024 updated by: Hala Ahmed Hashem, Assiut University

Ultrasound Assessment of Irrigation Fluid Effect on Extravascular Lung Water in Patients Undergoing Percutaneous Nephrolithotomy

Early detection of fluid accumulation in alveolar, interstitial and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of PNL guided by lung ultrasound by detection of sonographic B lines.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study protocol:

Anesthetic technique:- After adequate pre-oxygenation for 3-5 min, General anesthesia will be induced by intravenous lidocaine 60 mg, propofol (2mg/kg) and cis-atracurium (0.15 mg/ kg) to facilitate endotracheal intubation by a cuffed endotracheal tube (size 6.5-7.5-mm), then the patient will be connected to mechanical ventilation which will be maintained with an 8 ml/ kg tidal volume, and ventilation frequency well be adjusted to maintain end-tidal CO2 between 30-35 mmHg. Anesthesia will be maintained with isoflurane (0.8-1.0%) in a mixture of oxygen and air (50:50%) and cis-atracurium (0.03 mg/ kg) and maintained every 20 min. Standard monitoring will be used intraoperatively including non-invasive arterial blood pressure, electrocardiography, end-tidal CO2, peripheral oxygen saturation and esophageal core temperature. Patients will receive one liter of normal saline infused over the first 2 hours intraoperatively as their fasting requirements and will be infused with 3 ml/kg/hour of Ringer's acetate as a maintenance fluid. Intraoperative hypotension (more than 20% decrease of the baseline of the patient ) will be treated by a bolus dose of crystalloid (4 ml/kg) as well as a bolus dose of ephedrine (3 mg). Atropine (0.5 mg) will be used to treat bradycardia if the heart rate is <60 beat/min. At end of surgery, isoflurane will be discontinued, and neuromuscular block will be antagonized using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), intravenous paracetamol will be given as analgesia and boluses of fentanil Intraoperative as needed . Extubation will performed when patients began breathing spontaneously and were able to respond to verbal requests and discharge to post-Anesthesia Care Unit (PACU) but if the patient is not fulfilling criteria of extubation so discharge will be to Intensive care unit (ICU). If acute Postoperative lung congestion occurs with postoperative hypoxemia and desaturation, it will be treated with furosemide.

Blood samples will be collected for CBC, ABG and electrolytes as sodium and potassium Pre-operative, intraoperative and Immediately Post-operative.

Lung ultrasound scan technique: -

Each patient will be assessed for the presence of B-lines before induction of anesthesia and after end of anesthesia. A curved 2-6-MHz probe of Mindray machine will be used to do a series of scans with the patient in the supine position by applying the probe perpendicular to the skin over intercostal spaces along anatomical reference lines. More precisely, we will scan the anterolateral hemithoraxes along the parasternal, midclavicular, anterior axillary and mid-axillary lines. The left hemithorax will be scanned from the second to the fourth intercostal space, whereas the right lung will be scanned from the second to the fifth intercostal space, giving a total of 28 scanning sites. The edematous lung shows B-lines as vertical narrow bands originating from the pleural line and extending to the bottom of the image. A B-line score of ≤5 will be considered a normal sonographic pattern, since a few B-lines can be present in healthy subjects, especially above the diaphragm.

Data collection:- Patient characteristics

  • Age
  • Sex
  • Medical disease
  • Drug intake Operative data
  • Mean arterial blood pressure (MAP), heart rate and peripheral oxygen saturation during the following times (before induction of anesthesia, every 15 minutes after intubation, and at the end of surgery)
  • Intraoperative complication and interventions.
  • Duration of surgery
  • Duration of anesthesia
  • Type, volume and height of irrigation fluid.
  • Ultrasound guided extravascular lung water.

Postoperative data

  • Hemoglobin assessment.
  • Serum sodium level.
  • Serum potassium level.
  • Arterial blood gases (ABG).
  • Ultrasound guided extravascular lung water.

Statistical analysis:-

●Descriptive analysis Statistical analysis will be carried out by the SPSS statistical software package version 26.0 (IBM/SPSS, Inc., Chicago, IL). Baseline characteristics will be defined using descriptive statistics. Categorical variables were stated as an absolute number (n) and a relative frequency (%), and continuous variables will be represented as a median (interquartile range) or as a mean (± SD), depending on the normality of the distribution. The normality of distribution will be tested by the one-sample Kolmogorov-Smirnov test.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study will be carried on patients who are undergoing percutaneous nephrolithotomy under general anesthesia between Nov.2023 and Nov.2024.

Description

Inclusion Criteria:

  • ASA Class I, II or III adult patients of age group 18-65 years. •Patient undergoing percutaneous nephrolithotomy.

Exclusion Criteria:

  • •Patients unable to provide written consent.

    • Patients less than 18 years or above 65 years.
    • ASA Class IV.
    • Patients previously diagnosed to suffer from interstitial lung disease.
    • patients who will receive intraoperative diuretics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung congestion
Time Frame: 1 hour postoperative
Incidence of Post-operative lung congestion quantified by number of sonographic B-lines in anterolateral lung ultrasound scan in patients undergoing percutaneous nephrolithotomy.
1 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediately Post-operative and after 24hours postoperative hemoglobin assessment.
Time Frame: 1 hour postoperative
Immediately Post-operative and after 24hours postoperative hemoglobin assessment.
1 hour postoperative
Immediately Post-operative and after 24hours postoperative serum sodium and potassium assessment.
Time Frame: 1 hour postoperative
Immediately Post-operative and after 24hours postoperative serum sodium and potassium assessment.
1 hour postoperative
Immediately Post-operative and after 24hours postoperative arterial blood gases (ABG) assessment.
Time Frame: 1 hour postoperative
Immediately Post-operative and after 24hours postoperative arterial blood gases (ABG) assessment.
1 hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Essam Ezzat, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Extravascular lung water

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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