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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 provided
23/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is it safe to monitor non-invasive hemoglobin in major surgery?
Scientific title
Is it safe to monitor non-invasive hemoglobin in major surgery?
Secondary ID [1] 296910 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemoglobin concentration 310860 0
blood transfusion 310861 0
Condition category
Condition code
Blood 309531 309531 0 0
Other blood disorders
Anaesthesiology 309532 309532 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313181 0
Diagnosis / Prognosis
Comparator / control treatment
control group for blood transfusion treatment as a result of hemoglobin value with blood gas sampling
Control group
Active

Outcomes
Primary outcome [1] 308490 0
Total hemoglobin is monitored with pulse co-oximeter (Massimo, Irvine, CA) after perioperative blood transfusion
Timepoint [1] 308490 0
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.
Secondary outcome [1] 355147 0
Metabolic acidosis is determined by blood gas sampling by anesthesiologist.
Timepoint [1] 355147 0
during surgery and first 48 hours after surgery

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.
Minimum age
2 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/06/2018
Date of last participant enrolment
Anticipated
Actual
6/12/2018
Date of last data collection
Anticipated
Actual
9/12/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21141 0
Turkey
State/province [1] 21141 0
istanbul

Funding & Sponsors
Funding source category [1] 301479 0
Hospital
Name [1] 301479 0
Marmara university pendik Training and Education Hospital
Country [1] 301479 0
Turkey
Primary sponsor type
Individual
Name
Ayten saracoglu
Address
Marmara university pendik Training and Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak neighborhood, muhsin yazicioglu street, number:10 , 34899 pendik/istanbul
Country
Turkey
Secondary sponsor category [1] 301170 0
Individual
Name [1] 301170 0
meliha orhon ergun
Address [1] 301170 0
Marmara university pendik Training and Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak neighborhood, muhsin yazicioglu street, number:10 , 34899 pendik/istanbul
Country [1] 301170 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302223 0
Marmara university Clinical Researc Ethics Committee
Ethics committee address [1] 302223 0
Ethics committee country [1] 302223 0
Turkey
Date submitted for ethics approval [1] 302223 0
Approval date [1] 302223 0
02/06/2017
Ethics approval number [1] 302223 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89498 0
Dr meliha orhon ergün
Address 89498 0
Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
Country 89498 0
Turkey
Phone 89498 0
+905413402001
Fax 89498 0
Email 89498 0
dr.meliha@gmail.com
Contact person for public queries
Name 89499 0
Meliha Orhon Ergun
Address 89499 0
Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
Country 89499 0
Turkey
Phone 89499 0
+905413402001
Fax 89499 0
Email 89499 0
dr.meliha@gmail.com
Contact person for scientific queries
Name 89500 0
Meliha Orhon Ergun
Address 89500 0
Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street, number:10 34899 pendik/istanbul
Country 89500 0
Turkey
Phone 89500 0
+905413402001
Fax 89500 0
Email 89500 0
dr.meliha@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.