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Shoulder Arthropathy Associated With Other ConditionsNCT06104020

Effect of Liberal Versus Restrictive Intraoperative Fluid Therapy on Postoperative Pulmonary Complications and Hemodynamics in Patients Undergoing Shoulder Arthroscopic Surgery.

A study testing Intraoperative fluid management stratigies. in people with Shoulder Arthropathy Associated With Other Conditions, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intraoperative fluid management stratigies.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Nov 2024to 31 Dec 2025
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • Abnormal coagulation function.
  • Pregnancy
  • Refusal to Participate or Patients who cannot provide informed consent due to cognitive impairment or other reasons.
  • Previous shoulder arthroscopy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assuit university

    Asyut

Other trials in Egypt

About this study

Official title: Effect of Liberal Versus Restrictive Intraoperative Fluid Therapy on Postoperative Pulmonary Complications and Hemodynamics in Patients Undergoing Shoulder Arthroscopic Surgery

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.

Read the 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.

Being tested
Intraoperative fluid management stratigies.

What participants receive

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

  • 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.

Study groups in NCT06104020
Study groupRoleWhat they receive
Restrictive fluid group (RG)Active comparatorThe 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.
Receives: Other: Intraoperative fluid management stratigies.
liberal group (LG)Active comparatorThe 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].
Receives: Other: Intraoperative fluid management stratigies.

What is being measured

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

  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

    Measured: 1-One hour before the start of Surgery. 2-Two hours after the End of surgery.

Secondary outcomes (6)
  1. Blood Pressure

    Measured in millimeters of Mercury (mm Hg).

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

  2. Heart Rate

    Measured in Beats per Minute (bpm).

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

  3. Oxygen Saturation

    Measured in Percentage (%).

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

  4. Vasopressor Used and Dose

    Measured in milligrams (mg).

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

  5. Interval for Repeated Dose of the Vasopressor.

    Measured in minutes.

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

  6. Duration of Action of used Vasopressor

    Measured in Minutes.

    Measured: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

Timeline

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

  1. First posted27 Oct 2023
  2. Study start1 Nov 2024
  3. Primary completion1 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104020
Sponsor's protocol ID
assiut_ICU2012
Status last verified
Mar 2025
First submitted
8 Oct 2023
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29742967
  • 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.

    PubMed 26195827
  • 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.

    PubMed 25501898
  • 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.

    PubMed 14639165
  • 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.

    PubMed 21186092
  • 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.

    PubMed 21485693
  • 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.

    PubMed 23716767
  • 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.

    PubMed 20872997
  • 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.

    PubMed 1582282
  • 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.

    PubMed 8968197
  • 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.

    PubMed 19519723
  • 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.

    PubMed 22866958
  • 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.

    PubMed 14578723
  • 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.

    PubMed 11573596
  • 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.

    PubMed 7762845

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative fluid management stratigies. in people with Shoulder Arthropathy Associated With Other Conditions, run by Assiut University at 1 site in Egypt.

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lung ultrasound score (LUS) (time frame: 1-One hour before the start of Surgery. 2-Two hours after the End of surgery.). 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 NCT06104020, which also lists 17 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 16 Sep 2026.

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