CompletedPhase 1ACTRN12619001468112

Is it safe to monitor non-invasive hemoglobin in major surgery?


Sponsor

Ayten saracoglu

Enrollment

20 participants

Start Date

Jun 5, 2018

Study Type

Interventional

Conditions

Summary

Our primary aim in this prospective and observational study was to determine the effect of spHb monitor on perioperative blood transfusion in children undergoing craniocinocytosis surgery. Our secondary aim is to reveal the hemodynamic and metabolic changes in perioperative period in patients who underwent craniocinocytosis in the pediatric patient group who had severe metabolic acidosis in the perioperative period. In this study, our hypothesis is that blood management with continuous SpHb values during pediatric craniocinocytosis surgery will reduce the amount of transfusion and lead to less metabolic and hemodynamic instability compared to the management based on Hb measurement by intermittent blood sampling.


Eligibility

Sex: Both males and femalesMin Age: 2 MonthssMax Age: 24 Monthss

Inclusion Criteria1

  • children who will undergo craniosynostosis surgery, ASA I-II, 2-24 months of age and written informed consent from their families or legal officers will be included in the study.

Exclusion Criteria1

  • Children with congenital or traumatic extremity pathology, with a history of allergy to the sensor material and body weight of less than 3 kg, patients with rectal abnormalities, thus contraindicated for rectal temperature probe placement, patients undergoing emergency surgery, or known heart failure or hypertension children who have cardiac or vascular disease and who have developed a surgical complication during the operation will be excluded from the study.

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Interventions

This study was planned as a prospective, randomized and controlled study. Pediatric patients aged 2-24 months who underwent craniosynocytosis surgery were included in the study. The patients were divi

This study was planned as a prospective, randomized and controlled study. Pediatric patients aged 2-24 months who underwent craniosynocytosis surgery were included in the study. The patients were divided into two groups as control group and SpHb group managed by blood envelope method by means of closed envelope method by conventional intermittent blood gas sampling or by monitoring of hemoglobin (Hb) by SpHb measurement. 0-60-120-180-240 minutes following surgery commencement in patients in both groups. Hemoglobin monitoring was performed by arterial blood gas analysis at the end of the operation and at the end of the operation. In the SpHb group, Hb values obtained by continuous Hb analysis trend were recorded and simultaneous blood gas sampling was performed with sudden decreases in this trend. Blood transfusion was planned to be > 8 g / dl according to the recommendations of the European Society of Anesthesia (ESA) for perioperative bleeding management. Gender, age, body weight and ASA (American Society of Anesthesiologists) classification were recorded. All patients were intubated with rocuronium at a dose of 0.6 mg / kg with inhalation anesthesia induction using 60% oxygen + 40% air and 8% sevoflurane. During the operation, SpO2, invasive blood pressures, heart rate, central venous pressures (CVP), PVI (pleth variability index), body temperature, Hb and Hemotocrit (hct) values at the beginning and end of the operation, blood transfusion, perioperative , amount of crystalloid and colloid fluid, operation time, duration of anesthesia and urine output, vasopressor need and sevoflurane concentrations in expiratory air, all complications during perioperative period, duration of postoperative intensive care, amount of transfusion given, complications and Hb values were recorded. Patients in both groups were monitored with the M-LNCS Inf probe, which only measures PVI connected to the Radical-7 Pulse CO-Oximeter. Patients in the SpHb group were also monitored for continuous SpHb values with the Rainbow1 20L probe (Masimo, Irvine, CA) connected to the Radical-7 Pulse CO-Oximeter. After induction of anesthesia, the probe was placed on the ring finger of the non-dominant hand without arterial monitoring. The same technique and device were used for blood gas sampling in both groups. The arterial blood sample was taken into the blood gas injector with a 26 gauge radial cannula and analyzed immediately (GEN-S hematology analyzer, Beckman-Coulter Inc., Brea CA) and the results were recorded. Lactate, pH, BE, HCO3, lactate, Na, K, and glucose values were recorded in perioperative arterial blood gas sampling.


Locations(1)

istanbul, Turkey

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ACTRN12619001468112