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TUR SyndromeNCT06220734

Detection of the Effect of Irrigation Fluid on Extravascular Lung Water in Patients Undergoing TRUP Using Bedside Lung Ultrasound

An observational study of TUR Syndrome and Anesthesia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Early detection of fluid accumulation in alveolar, interstitial, and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of TURP guided by lung ultrasound by detection of sonographic B lines. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
TUR Syndrome, Anesthesia
What is being tested?
transurethral resection of the prostate
Type of treatment
Surgery or procedure
How many people
50 participants
Where
No sites listed yet
Study dates
5 Apr 2024to 5 Aug 2025
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 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: men attended at assuit university hospital, for underwent transurethral resection of the prostate and fulfilled inclusion criteria

Who may be able to join

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

Who cannot join

  • • 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

Trial locations and contacts

No sites are listed yet.

Monica Nabil ELcellini contact

+201095548405

monicanabil19@gmail.com

About this study

Official title: Early Detection of the Effect of Irrigation Fluid on Extravascular Lung Water in Patients Undergoing Transurethral Resection of a Prostate Using Bedside Lung Ultrasound

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

Read the detailed description

Endoscopic syndrome or TURP (transurethral resection of a prostate syndrome (TURP)) syndrome is an undesirable effect of prostatectomy through the urethra. The reason is that the lavage used in endoscopy is hypotonic fluid, without electrolytes absorbed into the lumen through the prostate venous sinuses, changing the circulating volume, disturbing the water balance of electrolytes, especially hyponatremia, and reducing serum osmolality, affecting on the cardiovascular system, respiratory and nervous system.1 Symptoms of TURP are often irregular, asynchronous, and nonspecific. Sometimes life-threatening complications such as sudden coma, heart failure, cardiovascular collapse and, respiratory failure2,3 are reported. Recent studies show that the incidence of TURP ranges from 0.78% to 1.4%. Although there are not many severe cases of TURP, the mortality rate is up to 25%.4,5

The TURP syndrome is a clinical diagnosis based upon a constellation of symptoms and signs associated with excessive absorption of irrigating fluid into the circulation. It comprises acute changes in intravascular volume, plasma solute concentrations, and osmolality, and direct effects of the irrigation fluid used (glycine and its metabolites in the UK, as glycine 1.5% is the most common irrigation fluid used). The effects are proportional to the volume of irrigating solution absorbed. The presentation is not always uniform, and milder cases may be unrecognized. Other types of endoscopic surgery that require the use of irrigation solution, e.g., hysteroscopy, may also give increase to the TURP syndrome.3

Mild-to-moderate TURP syndrome may occur in 1-8% of patients.3 The overall mortality is 0.2-0.8%. It may present as early as 15 min after resection starts or as late as 24 h after operation.6 Severe TURP syndrome is now rare; however, it carries a mortality of up to 25%.3

Irrigation fluid is absorbed at a rate of between 10- and 30-ml min-1 of operating time.6 Five to 20% of patients will absorb >1 litre.3

A higher rate of absorption is produced by several factors.

  1. The pressure of the irrigation fluid. The height of the bag should be kept as low as possible to achieve adequate flow of fluid. Seventy centimeters are usually satisfactory. However, the surgeon will frequently stop and drain the bladder to remove chippings; during this time, the hydrostatic pressure within the bladder is low.
  2. Low venous pressure, e.g., if the patient is hypovolemic or hypotensive.
  3. Prolonged surgery, especially >1 h, although this is now uncommon.
  4. Large blood loss, implying many open veins.
  5. Capsular perforation, or bladder perforation, allowing a large volume of irrigation fluid into the peritoneal cavity, where it is rapidly absorbed.

Acute volume changes affect the cardiovascular system. The rapid absorption of a large volume of irrigation fluid can cause hypertension with reflex bradycardia and can precipitate acute cardiac failure and pulmonary oedema. The magnitude of the hypertension is not related to the volume of fluid absorbed.

Rapid equilibration of hypotonic fluid with the extracellular fluid compartment may precipitate sudden hypotension in association with hypovolemia. Hypotension and hypovolemia may be compounded by the sympathetic block of spinal anesthesia. This secondary phase at the end of the operation is often the first sign suggestive of the TURP syndrome.

The guidelines for intraoperative intravenous (IV) fluid administration are poorly defined, and fluid administration varies from restrictive to liberal fluid administration.[7] The goals of intraoperative fluid administration should be to maintain proper volume in the circulation to maintain adequate tissue perfusion. Traditionally, a large volume of fluid is infused intraoperatively[8] with the belief that overnight fasting and the effect of anesthesia on ongoing blood loss during surgery lead to hypovolemia that results in reduced circulatory volume and diminished tissue perfusion.[9,10] In contrast, inadequate fluid administration may lead to circulatory instability, compromised tissue perfusion and complications such as prerenal acute renal failure.[10-12] Liberal fluid administration has concerns about pulmonary congestion or oedema, decreased wound healing, decreased tissue oxygenation and delayed recovery.[7]

Over the past decade, ultrasound and particularly lung ultrasound (LUS) has rapidly gained increasing importance as a monitoring and diagnostic tool in the intensive care unit (ICU) (13)

Yet, for several lung disorders typically associated with intensive care settings such as pulmonary edema, pneumonia, or pleural effusions, LUS has recently proven its superiority over other diagnostic invasive and non-invasive imaging techniques such as chest radiography or physical examinations like auscultation. Specifically, LUS provides a higher diagnostic value, is more cost-effective and especially easy to perform directly at the patient's bedside (14-18).

Sonographic visualization of B-lines-originally termed as comet-tail artifacts arising vertically from the hyperechoic pleural line-represents a promising alternative for assessment of lung water.20 Scoring of B-lines is typically performed by their summation from different intercostal spaces.19 Most commonly recommended, an extensive 28-sector protocol of the antero-lateral chest is used for evaluation of quantitative B-lines score.21,22.

Being tested
transurethral resection of the prostate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transurethral resection of the prostateProcedure or surgery

    transurethral resection of the prostate for indicated patients then US was done for early detection of fluid accumulation in the lungs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraoperative lung congestion quantified by number of sonographic B-lines in anterolateral lung ultrasound scan in patients undergoing TURP

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start5 Apr 2024 (estimated)
  3. Primary completion5 Apr 2025 (estimated)
  4. Study completion5 Aug 2025 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220734
Sponsor's protocol ID
US in Anesthesia
Status last verified
Jan 2024
First submitted
14 Jan 2024
Last updated
24 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gravenstein D. Transurethral resection of the prostate (TURP) syndrome: a review of the pathophysiology and management. Anesth Analg. 1997 Feb;84(2):438-46. doi: 10.1097/00000539-199702000-00037. No abstract available.

    PubMed 9024044
  • Gupta K, Rastogi B, Jain M, Gupta PK, Sharma D. Electrolyte changes: An indirect method to assess irrigation fluid absorption complications during transurethral resection of prostate: A prospective study. Saudi J Anaesth. 2010 Sep;4(3):142-6. doi: 10.4103/1658-354X.71505.

    PubMed 21189849

Questions about this trial

What is this clinical trial studying?

An observational study of TUR Syndrome and Anesthesia, run by Assiut University.

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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Monica Nabil ELcellini (+201095548405, monicanabil19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative lung congestion quantified by number of sonographic B-lines in anterolateral lung ultrasound scan in patients undergoing TURP (time frame: 1 year). 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 NCT06220734, which also lists 2 linked publications.

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 24 Jan 2024.

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