Lung Ultrasound-Guided Intraoperative Fluid Management Strategies

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104020
Collaborator
(none)
60
2
13

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intraoperative fluid management stratigies.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. lung ultrasound score (LUS) [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

Secondary Outcome Measures

  1. Blood Pressure [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).

  2. Heart Rate [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).

  3. Oxygen Saturation [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 (%).

  4. Vasopressor Used and Dose [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).

  5. Interval for Repeated Dose of the Vasopressor. [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.

  6. Duration of Action of used Vasopressor [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aia Abdelhameed mohamed mohamed, Resident physician, Assiut University
ClinicalTrials.gov Identifier:
NCT06104020
Other Study ID Numbers:
  • assiut_ICU2012
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 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
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023