Conventional Fluid Management vs Plethysmographic Variability Index -Based Goal Directed Fluid Management

NCT05239286 | Completed DMC

• 1 other identifier: MD-179-2020
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Plethysmographic variability index is a dynamic method for evaluation of volume status which depends on estimation of respiratory variations in pulse oximeter waveform amplitude. The PVI has been studied in various patient populations and clinical settings, and has been shown to reliably predict fluid responsiveness and guide fluid resuscitation. conventional fluid management. Fluid replacement is managed according to clinical assessment, heart rate, arterial blood pressure and central venous pressure monitoring. However, clinical studies indicate that changes in ABP cannot be used for the monitoring of stroke volume and cardiac output. Another method is the goal-directed fluid management and it is based on individualized fluid management using static and dynamic parameters.

Conditions

Fluid Management During Elective Spine Surgeries

Outcome Measures

Primary Outcomes (1)

• The total intraoperative crystalloid consumption

  the total volume of infused crystalloids intraoperatively.

  3 hours

Secondary Outcomes (7)

• Plethysmographic variability index

  3 hours

• perfusion index

  3 hours

• mean arterial blood pressure

  3 hours

• Heart rate

  3 hours

• Blood lactate level

  3 hours

Study Arms (2)

Group conventional

ACTIVE COMPARATOR

Procedure: General anaesthesia; Drug: Conventional fluid managment

Group PVI

EXPERIMENTAL

Procedure: General anaesthesia; Drug: PVI dependant goal directed fluid therapy

Interventions

General anaesthesia PROCEDURE

All patients in supine position will receive breathing 100% oxygen, induction of anaesthesia will be achieved using propofol (2 mg/Kg), 1-2 mcg/kg of fentanyl and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Patients who will experience prolonged airway instrumentation due to a difficult intubation will be excluded from further data analysis because of excessive stimulation. Then mechanical ventilation will be performed using a tidal volume of 6-8 mL/kg of ideal body weight at an inspiratory to expiratory ratio of 1:2 without positive end-expiratory pressure. The ventilatory frequency will be adjusted to maintain an end-tidal carbon dioxide tension of 35-40 mmHg. Anaesthesia will be maintained by isoflurane (1-1.5%), atracurium 10 mg intravenous increments every 20 minutes and morphine 0.1 mg/kg intravenous will be given as a long acting analgesia.

Group PVI; Group conventional

Conventional fluid managment DRUG

Ringer solution at the dose of 5 ml/kg/h infused throughout the surgical procedure by taking the parameters such as Heart rate (HR), mean arterial pressure (MAP) and urine output, Hypotension was defined as a condition in which the MAP was below 30% of the baseline MAP of the patient. In this case, bolus of 250 ml crystalloids (0.9% NaCl) was given and in case of hypotension persistence, 5 mg I.V. ephedrine administered and repeated every 5 min till the MAP increased over 70% of baseline.

Group conventional

PVI dependant goal directed fluid therapy DRUG

After the induction of anesthesia, Ringer solution infused at the dose of 2 ml/kg/h started as a basal rate of infusion. If the PVI was higher than 13% for more than 5 min, a 250-ml bolus of crystalloids administrated. If the PVI was still higher than 13% after the bolus, it was repeated every 5 min until the PVI was less than 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline. In the cases where PVI was less than \< 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline. Then the patient was turned to prone position and the same steps according to Massimo readings were repeated.

Group PVI

Eligibility Criteria

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

You may qualify if:

• Adult patients (18-65 years)
• ASA I-II
• Patients scheduled for elective lumbar spine surgeries (e.g.: Lumbar fixation and simple discectomy) under general anaesthesia in prone position.

You may not qualify if:

• Operations which will last for less than 15 minutes. (e.g.: plate and screw adjustment or incomplete terminated surgery)
• Patients with cardiac morbidities e.g. history of unstable angina, impaired contractility with ejection fraction \< 40%, wall motional abnormalities or tight valvular lesions detected by echocardiography, previous cardiac operations or cardiac catherization with stent.
• Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
• Patient with decompensated respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
• Patients with peripheral vascular disease or long-standing DM affecting PVI readings.
• Complicated surgeries (huge spine tumors, intraoperative vascular or neurological complications and prolonged durations more than 5 hours) or surgeries with massive blood loss (4 units of packed RBCs in 1 hour or replacement of 50% of total blood volume within 3 hours )
• Pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Kasr Alaini

Cairo, 1772, Egypt

Location

Related Publications (4)

• Cesur S, Cardakozu T, Kus A, Turkyilmaz N, Yavuz O. Comparison of conventional fluid management with PVI-based goal-directed fluid management in elective colorectal surgery. J Clin Monit Comput. 2019 Apr;33(2):249-257. doi: 10.1007/s10877-018-0163-y. Epub 2018 Jun 14.

  PMID: 29948666 BACKGROUND

• McDermid RC, Raghunathan K, Romanovsky A, Shaw AD, Bagshaw SM. Controversies in fluid therapy: Type, dose and toxicity. World J Crit Care Med. 2014 Feb 4;3(1):24-33. doi: 10.5492/wjccm.v3.i1.24. eCollection 2014 Feb 4.

  PMID: 24834399 BACKGROUND

• Coutrot M, Joachim J, Depret F, Millasseau S, Nougue H, Mateo J, Mebazaa A, Gayat E, Vallee F. Noninvasive continuous detection of arterial hypotension during induction of anaesthesia using a photoplethysmographic signal: proof of concept. Br J Anaesth. 2019 May;122(5):605-612. doi: 10.1016/j.bja.2019.01.037. Epub 2019 Mar 11.

  PMID: 30916032 BACKGROUND

• Abdelhamid B, Matta M, Rady A, Adel G, Gamal M. Conventional fluid management versus plethysmographic variability index-based goal directed fluid management in patients undergoing spine surgery in the prone position - a randomised control trial. Anaesthesiol Intensive Ther. 2023;55(3):186-195. doi: 10.5114/ait.2023.130792.

  PMID: 37728446 DERIVED

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Bassant M Abdelhamid, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 14, 2022
• Study Start: January 24, 2022
• Primary Completion: August 24, 2022
• Study Completion: September 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)