Lung Ultrasound-Guided Intraoperative Fluid Management Strategies

March 5, 2024 updated by: Aia Abdelhameed mohamed mohamed, Assiut University

Randomized Controlled Trial of Lung Ultrasound-Guided Intraoperative Fluid Management Strategies: Assessing Their Impact on Post-operative Pulmonary Complications and Hemodynamics in Shoulder Arthroscopic Surgerys

The primary aim of our study is to leverage lung ultrasound to assess and identify postoperative pulmonary complications following shoulder arthroscopic surgery and the implications of the used irrigation fluid.the investigators will further investigate the impact of intraoperative fluid management strategies on these Postoperative pulmonary complications and their effects on hemodynamics. By harnessing the potential of lung ultrasound in this context, we aspire to enhance both the diagnostic capabilities and overall safety of shoulder arthroscopic surgery, ultimately improving patient outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Shoulder arthroscopy, a minimally invasive surgical technique, has become a preferred method for addressing conditions like rotator cuff tears and recurrent joint instability due to its advantages, such as reduced post-operative pain and quicker rehabilitation. However, recent attention has shifted to potential complications, including issues related to irrigation fluid, patient positioning in the beach-chair posture, and anesthesia protocols. One key concern is the use of pressurized irrigation fluid, which, while essential for visualization, carries the risk of complications, including subcutaneous emphysema, pneumomediastinum, tension pneumothorax, air embolism, pulmonary edema, and atelectasis. These complications can have systemic effects, emphasizing the need for precise intraoperative fluid management.

Intraoperative fluid management strategies are a subject of continuous debate in the field of surgery, giving rise to three main strategies: 'liberal,' 'restricted,' and 'goal-directed' fluid therapy. These strategies vary in terms of the type of fluid used, timing of administration, and volume administered. While administering large volumes of fluids may improve organ perfusion, it may also increase the incidence of perioperative cardiopulmonary complications. Conversely, fluid restriction may reduce the length of hospital stay but increase the risk of postoperative acute kidney injury. Goal-directed therapy, which tailors fluid administration based on reproducible endpoints, has been associated with improved perioperative outcomes. The Bezold-Jarisch reflex is a cardiovascular reflex that can result in severe bradycardia and vasodilation when activated, especially in fasting patients with beach-chair position and other positions that lead to pooling of the blood in the lower limb and, in turn, lead to a decrease in venous return.

Understanding the intricate relationship between this reflex and intraoperative fluid management is paramount for improving patient safety and surgical outcomes. This reflex can be triggered by various factors, including rapid fluid administration and alterations in venous return, particularly in patients positioned in the beach chair posture.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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

  • Name: Mohamed Kilany Ali Abdelsalam, M.B.B.Ch/ Ph.D / M.Sc
  • Phone Number: +201090030029
  • Email: Mohamedkelany@aun.edu.eg

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

No

Description

Inclusion Criteria:

  • Patients scheduled for elective shoulder arthroscopic surgery.
  • Adults aged 18 years and above.
  • Capable of providing informed consent voluntarily.
  • No known allergies or sensitivities to substances commonly used in the surgical procedure or study.
  • Stable baseline hemodynamics during preoperative evaluation

Exclusion Criteria:

  • Patients scheduled for open shoulder surgery.

  • Medical Comorbidities:

    • Pulmonary diseases, including chronic pulmonary diseases or pulmonary edema.
    • Previous cardiac diseases such as heart failure, myocardial infarction (MI), hypertension, and known types of arrhythmia.
  • Severe Organ Disease: Severe liver or kidney disease.
  • Body mass index (BMI) ≥ 35 kg/m².
  • Abnormal coagulation function.
  • Pregnancy
  • Refusal to Participate or Patients who cannot provide informed consent due to cognitive impairment or other reasons.
  • Previous shoulder arthroscopy.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Restrictive fluid group (RG)
The restrictive fluid group (RG) aims to achieve a net zero fluid balance and involves a 2 mL/kg bolus at anesthesia induction, followed by an intraoperative crystalloid infusion at a rate of 4 mL/kg/hr.
Other: Intraoperative fluid management stratigies.

Regimens of different intraoperative fluid management The restrictive fluid group (RG) aims to achieve a net zero fluid balance and involves a 2 mL/kg bolus at anesthesia induction, followed by an intraoperative crystalloid infusion at a rate of 4 mL/kg/hr.

The other group of patients, the liberal group (LG), will receive a 10 ml/kg bolus at anesthesia induction,followed by an intraoperative crystalloid infusion at a rate of 8 ml/kg/hr.
Active Comparator: liberal group (LG)
The liberal group (LG) will receive a 10 mL/kg bolus at anesthesia induction, followed by an intraoperative crystalloid infusion at a rate of 8 mL/kg/hr [12, 13].
Other: Intraoperative fluid management stratigies.

Regimens of different intraoperative fluid management The restrictive fluid group (RG) aims to achieve a net zero fluid balance and involves a 2 mL/kg bolus at anesthesia induction, followed by an intraoperative crystalloid infusion at a rate of 4 mL/kg/hr.

The other group of patients, the liberal group (LG), will receive a 10 ml/kg bolus at anesthesia induction,followed by an intraoperative crystalloid infusion at a rate of 8 ml/kg/hr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lung ultrasound score (LUS)
Time Frame: 1-One hour before the start of Surgery. 2-Two hours after the End of surgery.

we will Identify postoperative pulmonary complications using the lung ultrasound score (LUS) following shoulder arthroscopic surgery to assess the implications of the used irrigation fluid and The intraoperative Fluid infusion

  • 0 = normal lung aeration,
  • 1 = moderate loss of aeration
  • 2 = severe loss of aeration
  • 3 = complete loss of lung aeration
1-One hour before the start of Surgery. 2-Two hours after the End of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in millimeters of Mercury (mm Hg).
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Heart Rate
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in Beats per Minute (bpm).
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Oxygen Saturation
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in Percentage (%).
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Vasopressor Used and Dose
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in milligrams (mg).
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Interval for Repeated Dose of the Vasopressor.
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in minutes.
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Duration of Action of used Vasopressor
Time Frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.
Measured in Minutes.
Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

Collaborators and Investigators

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

Sponsor

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)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assiut_ICU2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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