Lung Ultrasound-Guided Intraoperative Fluid Management Strategies

Shoulder Arthropathy Associated With Other Conditions Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104020
• Other study ID #: assiut_ICU2012
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Aia Abdelhameed mohamed
• Phone: 01060809150
• Email: aiaomerr1997[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Shoulder Arthropathy Associated With Other Conditions

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (17)

Bhaskar SB, Manjuladevi M. Shoulder arthroscopy and complications: Can we afford to relax? Indian J Anaesth. 2015 Jun;59(6):335-7. doi: 10.4103/0019-5049.158729. No abstract available. — View Citation

Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available. — View Citation

Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23. — View Citation

Bundgaard-Nielsen M, Secher NH, Kehlet H. 'Liberal' vs. 'restrictive' perioperative fluid therapy--a critical assessment of the evidence. Acta Anaesthesiol Scand. 2009 Aug;53(7):843-51. doi: 10.1111/j.1399-6576.2009.02029.x. Epub 2009 Jun 10. — View Citation

D'Alessio JG, Weller RS, Rosenblum M. Activation of the Bezold-Jarisch reflex in the sitting position for shoulder arthroscopy using interscalene block. Anesth Analg. 1995 Jun;80(6):1158-62. doi: 10.1097/00000539-199506000-00016. — View Citation

Ichai C, Ciais JF, Roussel LJ, Levraut J, Candito M, Boileau P, Grimaud D. Intravascular absorption of glycine irrigating solution during shoulder arthroscopy: a case report and follow-up study. Anesthesiology. 1996 Dec;85(6):1481-5. doi: 10.1097/00000542-199612000-00031. No abstract available. — View Citation

Jirativanont T, Tritrakarn TD. Upper airway obstruction following arthroscopic rotator cuff repair due to excess irrigation fluid. Anaesth Intensive Care. 2010 Sep;38(5):957-8. No abstract available. — View Citation

Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859. — View Citation

Lee HC, Dewan N, Crosby L. Subcutaneous emphysema, pneumomediastinum, and potentially life-threatening tension pneumothorax. Pulmonary complications from arthroscopic shoulder decompression. Chest. 1992 May;101(5):1265-7. doi: 10.1378/chest.101.5.1265. — View Citation

Manjuladevi M, Gupta S, Upadhyaya KV, Kutappa AM. Postoperative airway compromise in shoulder arthroscopy: A case series. Indian J Anaesth. 2013 Jan;57(1):52-5. doi: 10.4103/0019-5049.108563. — View Citation

Mongodi S, Bouhemad B, Orlando A, Stella A, Tavazzi G, Via G, Iotti GA, Braschi A, Mojoli F. Modified Lung Ultrasound Score for Assessing and Monitoring Pulmonary Aeration. Ultraschall Med. 2017 Oct;38(5):530-537. doi: 10.1055/s-0042-120260. Epub 2017 Mar 14. — View Citation

Myles P, Bellomo R, Corcoran T, Forbes A, Wallace S, Peyton P, Christophi C, Story D, Leslie K, Serpell J, McGuinness S, Parke R; Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial. BMJ Open. 2017 Mar 3;7(3):e015358. doi: 10.1136/bmjopen-2016-015358. — View Citation

Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9. — View Citation

Orebaugh SL. Life-threatening airway edema resulting from prolonged shoulder arthroscopy. Anesthesiology. 2003 Dec;99(6):1456-8. doi: 10.1097/00000542-200312000-00034. No abstract available. — View Citation

Prowle JR, Chua HR, Bagshaw SM, Bellomo R. Clinical review: Volume of fluid resuscitation and the incidence of acute kidney injury - a systematic review. Crit Care. 2012 Aug 7;16(4):230. doi: 10.1186/cc11345. — View Citation

Rains DD, Rooke GA, Wahl CJ. Pathomechanisms and complications related to patient positioning and anesthesia during shoulder arthroscopy. Arthroscopy. 2011 Apr;27(4):532-41. doi: 10.1016/j.arthro.2010.09.008. Epub 2010 Dec 24. — View Citation

Saeki N, Kawamoto M. Tracheal obstruction caused by fluid extravasation during shoulder arthroscopy. Anaesth Intensive Care. 2011 Mar;39(2):317-8. No abstract available. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung ultrasound score (LUS)	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	Blood Pressure	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.
Secondary	Heart Rate	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.
Secondary	Oxygen Saturation	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.
Secondary	Vasopressor Used and Dose	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.
Secondary	Interval for Repeated Dose of the Vasopressor.	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.
Secondary	Duration of Action of used Vasopressor	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.