Clinical trial NCT05239286: Conventional Fluid Management vs Plethysmographic Variability Index -Based Goal Directed Fluid Management
Official title: Comparison Between Conventional Fluid Management and Plethysmographic Variability Index Based Goal Directed Fluid Management in Patients Undergoing Spine Surgeries in Prone Position; A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Management During Elective Spine Surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study aims to compare the conventional fluid managment and Plethysmographic Variability index based during elective spine surgeries in prone position.

the study hypothesize is: plethysmographic variability index (PVI) based fluid management is more accurate than conventional method in preventing hypovolemia ana hypotension associated with prone position.

The patients will be randomly assigned into two equal groups using computer-generated random numbers with closed envelop, each of which will include 33 patients.

Group conventional: (n=33) patients are in the conventional fluid management group.

Group PVI: (n=33) patients are in the PVI-based goal-directed fluid management group.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: The total intraoperative crystalloid consumption
timeFrame: 3 hours
Secondary outcomes:
measure: Plethysmographic variability index
timeFrame: 3 hours
measure: perfusion index
timeFrame: 3 hours
measure: mean arterial blood pressure
timeFrame: 3 hours
measure: Heart rate
timeFrame: 3 hours
measure: Blood lactate level
timeFrame: 3 hours
measure: Total amount of intraoperative urine output
timeFrame: 3 hours
measure: The need and the amount of intraoperative blood transfusion
timeFrame: 3 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Kasr Alaini
Study officials:
affiliation: Cairo University
name: Bassant M Abdelhamid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.