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Trial registered on ANZCTR
Registration number
ACTRN12619001468112
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
23/10/2019
Date last updated
22/06/2021
Date data sharing statement initially provided
23/10/2019
Date results information initially provided
23/10/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Is it safe to monitor non-invasive hemoglobin in major surgery?
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Scientific title
Is it safe to monitor non-invasive hemoglobin in major surgery?
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Secondary ID [1]
296910
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
hemoglobin concentration
310860
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blood transfusion
310861
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Condition category
Condition code
Blood
309531
309531
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0
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Other blood disorders
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Anaesthesiology
309532
309532
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
313181
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Diagnosis / Prognosis
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Comparator / control treatment
control group for blood transfusion treatment as a result of hemoglobin value with blood gas sampling
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Control group
Active
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Outcomes
Primary outcome [1]
308490
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Total hemoglobin is monitored with pulse co-oximeter (Massimo, Irvine, CA) after perioperative blood transfusion
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Assessment method [1]
308490
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Timepoint [1]
308490
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The measurements will be done at 0-60-120-180-240 minutes following the onset of surgery and at the end of the surgery. Hemoglobin monitoring will be performed by pulse co-oximeter (Masimo, Irvine, CA ) and with arterial blood gas sampling at certain times.
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Secondary outcome [1]
355147
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Metabolic acidosis is determined by blood gas sampling by anesthesiologist.
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Assessment method [1]
355147
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Timepoint [1]
355147
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during surgery and first 48 hours after surgery
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Eligibility
Key inclusion criteria
20 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.
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Minimum age
2
Months
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Maximum age
24
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/06/2018
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Date of last participant enrolment
Anticipated
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Actual
6/12/2018
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Date of last data collection
Anticipated
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Actual
9/12/2018
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
21141
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Turkey
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State/province [1]
21141
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istanbul
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Funding & Sponsors
Funding source category [1]
301479
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Hospital
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Name [1]
301479
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Marmara university pendik Training and Education Hospital
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Address [1]
301479
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Marmara university pendik Training and Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak neighborhood, muhsin yazicioglu street, number:10 , 34899 pendik/istanbul
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Country [1]
301479
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Turkey
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Primary sponsor type
Individual
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Name
Ayten saracoglu
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Address
Marmara university pendik Training and Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak neighborhood, muhsin yazicioglu street, number:10 , 34899 pendik/istanbul
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Country
Turkey
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Secondary sponsor category [1]
301170
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Individual
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Name [1]
301170
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meliha orhon ergun
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Address [1]
301170
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Marmara university pendik Training and Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak neighborhood, muhsin yazicioglu street, number:10 , 34899 pendik/istanbul
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Country [1]
301170
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302223
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Marmara university Clinical Researc Ethics Committee
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Ethics committee address [1]
302223
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Basibuyuk Neighborhood,number:2 , 34854 Maltepe/istanbul
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Ethics committee country [1]
302223
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Turkey
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Date submitted for ethics approval [1]
302223
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Approval date [1]
302223
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02/06/2017
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Ethics approval number [1]
302223
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
89498
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Dr meliha orhon ergün
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Address
89498
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Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
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Country
89498
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Turkey
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Phone
89498
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+905413402001
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Fax
89498
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Email
89498
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[email protected]
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Contact person for public queries
Name
89499
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Dr Meliha Orhon Ergun
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Address
89499
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Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
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Country
89499
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Turkey
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Phone
89499
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+905413402001
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Fax
89499
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Email
89499
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[email protected]
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Contact person for scientific queries
Name
89500
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Dr Meliha Orhon Ergun
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Address
89500
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Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
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Country
89500
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Turkey
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Phone
89500
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+905413402001
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Fax
89500
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Email
89500
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Continuous SpHb values during pediatric craniosyno...
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Documents added automatically
No additional documents have been identified.
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