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Trial registered on ANZCTR
Registration number
ACTRN12620000553976
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
11/05/2020
Date last updated
11/05/2020
Date data sharing statement initially provided
11/05/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of hyperoxia in pediatric patient via oxygen reserve index monitoring
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Scientific title
Prevention of harmfull effect of hyperoxia with new monitorization method : ORI (oxygen reserve index )
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Secondary ID [1]
296918
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None
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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:
skull bone malformation
314463
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Musculoskletal malformation
314464
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anesthesiology
314465
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Condition category
Condition code
Musculoskeletal
312797
312797
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
2-24 months old children who will undergo craniocinocytosis surgery will be included in the study.
Patients will be preoxygenated using 100% inspiratory oxygen concentration + air. Patients will be given inhalation anesthesia with 2% sevoflurane.In induction, after intubation, 60-, 120-, 180- and 240-minute arterial blood gas samples will be taken to determine PaO2.During this process, SpO2 and Oxygen reserve index (ORI) values of the patients will be recorded continuously by anaeshesiologist via memorystick.
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Intervention code [1]
313191
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
308494
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Our primary goal in this prospective study was to compare the oxygen reserve index with the Rainbow1 20L probe connected to the Radical-7 Pulse CO-Oximeter (Masimo, Irvine, CA), in patients undergoing preoxygenation with the same inspiratory oxygen concentration.
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Assessment method [1]
308494
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Timepoint [1]
308494
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In induction, after intubation, 60-, 120-, 180- and 240-minute arterial blood gas samples will be taken
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Secondary outcome [1]
376929
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Desaturation of the pulse oxymeter values.
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Assessment method [1]
376929
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Timepoint [1]
376929
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24 hours
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Secondary outcome [2]
376930
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postoperative Atelectasis will determine on chest x-RAY .
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Assessment method [2]
376930
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Timepoint [2]
376930
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48 hours
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Eligibility
Key inclusion criteria
20 children who will undergo craniocinocytosis 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 with cardiac or vascular disease will be excluded from the study.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
SPSS 22.0 program will be used in the analyzes and mean, standard deviation, median lowest, maximum, frequency and ratio values will be used in the descriptive statistics of the data.The distribution of variables will be measured by the kolmogorov smirnov test.In the analysis of quantitative data mann-whitney u test will be used. The wilcoxon test will be used in the analysis of recurrent measurements. Spearman correlation analysis will be used in the correlation analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/07/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21142
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Turkey
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State/province [1]
21142
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Istanbul
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Funding & Sponsors
Funding source category [1]
301489
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University
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Name [1]
301489
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Marmara University Medical Faculty
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Address [1]
301489
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Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
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Country [1]
301489
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Turkey
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Primary sponsor type
University
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Name
Marmara University Medical Faculty
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Address
Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
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Country
Turkey
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Secondary sponsor category [1]
301183
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None
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Name [1]
301183
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Address [1]
301183
0
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Country [1]
301183
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302233
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Marmara University Ethics Committee
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Ethics committee address [1]
302233
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Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
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Ethics committee country [1]
302233
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Turkey
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Date submitted for ethics approval [1]
302233
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Approval date [1]
302233
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03/11/2017
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Ethics approval number [1]
302233
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09.2017.660
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Summary
Brief summary
Our primary goal in this prospective study was to compare the oxygen reserve index and arterial oxygen pressure in patients undergoing preoxygenation with inspiratory oxygen at different concentrations. 2-24 months old children who will undergo craniocinocytosis surgery will be included in the study. Patients will be preoxygenated using 100% inspiratory oxygen concentration and air. During this process, SpO2 and ORI values of the patients will be recorded continuously .The ORI values will be monitored continuously with the Rainbow1 20L probe (Masimo, Irvine, CA) connected to the Radical-7 Pulse CO-Oximeter. After induction of anesthesia, the probe will be placed on the ring finger of the non dominant and the arterial monitoring is not performed hand , according to the recommendations of the manufacturer and wrapped to prevent any environmental factors. Preoxygenation and tracheal intubation will be carried out by the same anesthesiologist. Invasive artery monitorization and central venous pressure, catheterizations will be performed.
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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
89530
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A/Prof Ayten Saracoglu
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Address
89530
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Marmara Universitesi Pendik EAH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
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Country
89530
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Turkey
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Phone
89530
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+905377810144
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Fax
89530
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Email
89530
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[email protected]
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Contact person for public queries
Name
89531
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Seniyye Zengin
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Address
89531
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Marmara Universitesi Pendik EAH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
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Country
89531
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Turkey
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Phone
89531
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+905057142443
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Fax
89531
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Email
89531
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[email protected]
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Contact person for scientific queries
Name
89532
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Seniyye Zengin
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Address
89532
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Marmara Universitesi Pendik E.AH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
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Country
89532
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Turkey
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Phone
89532
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+905057142443
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Fax
89532
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Email
89532
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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
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The outcomes of using high oxygen concentration in pediatric patients.
2022
https://dx.doi.org/10.1007/s10877-021-00765-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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