Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Prevention of harmfull effect of hyperoxia with new monitorization method : ORI (oxygen reserve index )
Secondary ID [1] 296918 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skull bone malformation 314463 0
Musculoskletal malformation
314464 0
anesthesiology 314465 0
Condition category
Condition code
Musculoskeletal 312797 312797 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313191 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308494 0
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.
Timepoint [1] 308494 0
In induction, after intubation, 60-, 120-, 180- and 240-minute arterial blood gas samples will be taken
Secondary outcome [1] 376929 0
Desaturation of the pulse oxymeter values.
Timepoint [1] 376929 0
24 hours
Secondary outcome [2] 376930 0
postoperative Atelectasis will determine on chest x-RAY .
Timepoint [2] 376930 0
48 hours

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.
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 with cardiac or vascular disease will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/07/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 21142 0
Turkey
State/province [1] 21142 0
Istanbul

Funding & Sponsors
Funding source category [1] 301489 0
University
Name [1] 301489 0
Marmara University Medical Faculty
Country [1] 301489 0
Turkey
Primary sponsor type
University
Name
Marmara University Medical Faculty
Address
Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
Country
Turkey
Secondary sponsor category [1] 301183 0
None
Name [1] 301183 0
Address [1] 301183 0
Country [1] 301183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302233 0
Marmara University Ethics Committee
Ethics committee address [1] 302233 0
Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
Ethics committee country [1] 302233 0
Turkey
Date submitted for ethics approval [1] 302233 0
Approval date [1] 302233 0
03/11/2017
Ethics approval number [1] 302233 0
09.2017.660

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89530 0
A/Prof Ayten Saracoglu
Address 89530 0
Marmara Universitesi Pendik EAH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
Country 89530 0
Turkey
Phone 89530 0
+905377810144
Fax 89530 0
Email 89530 0
[email protected]
Contact person for public queries
Name 89531 0
Dr Seniyye Zengin
Address 89531 0
Marmara Universitesi Pendik EAH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
Country 89531 0
Turkey
Phone 89531 0
+905057142443
Fax 89531 0
Email 89531 0
[email protected]
Contact person for scientific queries
Name 89532 0
Dr Seniyye Zengin
Address 89532 0
Marmara Universitesi Pendik E.AH Fevzi Çakmak Mahallesi Muhsin Yazicioglu caddesi no:11 Kaynarca Pendik
Country 89532 0
Turkey
Phone 89532 0
+905057142443
Fax 89532 0
Email 89532 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe outcomes of using high oxygen concentration in pediatric patients.2022https://dx.doi.org/10.1007/s10877-021-00765-2
N.B. These documents automatically identified may not have been verified by the study sponsor.