Lung Ultrasound-Guided Intraoperative Fluid Management Strategies

NCT06104020 | Not Yet Recruiting

• 1 other identifier: assiut_ICU2012
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Arthropathy Associated With Other Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Restrictive fluid group (RG)

ACTIVE COMPARATOR

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.

liberal group (LG)

ACTIVE COMPARATOR

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.

Interventions

Intraoperative fluid management stratigies. OTHER

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.

Restrictive fluid group (RG); liberal group (LG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (17)

• 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.

  PMID: 29742967 BACKGROUND

• 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.

  PMID: 26195827 BACKGROUND

• 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.

  PMID: 25501898 BACKGROUND

• 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.

  PMID: 14639165 BACKGROUND

• 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.

  PMID: 21186092 BACKGROUND

• 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.

  PMID: 21485693 BACKGROUND

• 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.

  PMID: 23716767 BACKGROUND

• 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.

  PMID: 20872997 BACKGROUND

• 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.

  PMID: 1582282 BACKGROUND

• 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.

  PMID: 8968197 BACKGROUND

• 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.

  PMID: 19519723 BACKGROUND

• 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.

  PMID: 22866958 BACKGROUND

• 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.

  PMID: 14578723 BACKGROUND

• 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.

  PMID: 11573596 BACKGROUND

• 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.

  PMID: 7762845 BACKGROUND

• 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.

  PMID: 28259855 BACKGROUND

• 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.

  PMID: 28291991 BACKGROUND

Central Study Contacts

Aia Abdelhameed mohamed

CONTACT

01060809150; aiaomerr1997@gmail.com

Mohamed Kilany Ali Abdelsalam, M.B.B.Ch/ Ph.D / M.Sc

CONTACT

+201090030029; Mohamedkelany@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share