Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001581156
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
18/11/2019
Date last updated
3/03/2023
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
3/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxygen Reserve Index Monitorization in Minimally Invasive Surgery for Thoracic deformity
Scientific title
Oxygen Titration with Oxygen Reserve Index in Minimally Invasive Repair of Pectus Excavatum
Secondary ID [1] 296919 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pneumothorax 310870 0
hypoxemia 310871 0
hyperoxemia 311039 0
Condition category
Condition code
Surgery 309542 309542 0 0
Surgical techniques
Respiratory 309543 309543 0 0
Other respiratory disorders / diseases
Anaesthesiology 309544 309544 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 128 patients under 18 years age undergoing elective minimal invasive repair of pectus excavatum (MIRPE) surgery will be recruited. The patients will be randomized into two groups by sealed envelope method. In the control group (Group C) patients will be followed up with continuous SpO2 measurement as standard. In the study group (Group O) continuous oxygen reserve index (ORI) monitoring together with perfusion index (PI) measurements in addition to SpO2 will be applied. ORI values will be monitored by Root® with Radical-7® (Masimo Corp., Irvine, CA, USA) device. Standard intravenous general anesthesia induction (propofol 2-3 mg/kg, remifentanil 0.5-1 µg/kg and rocuronium bromide 0.6 mg/kg) and desflurane-remifentanil based maintenance (desflurane 6% in oxygen-air mixture and remifentanil infusion at a rate of 0.1-0.25 µg/kg/min) will be used. The patients’ demographic variables; comorbidities; operation and anesthesia durations; amount of intravenous fluid administered intraoperatively; pre-induction, pre-first and -second pneumothorax, and postoperative ORI values, mean arterial pressure, temperature, PI, end-tidal carbon dioxide levels will be recorded; as well as postoperative complications, and lengths of hospital stays.
After induction, FiO2 will be adjusted to 40% and titrated between 60-100% with the onset of pneumothorax according to the decrease in ORI in Group O and SpO2 in Group C. A decrease of 0.05 from the highest ORI value will be accepted as the beginning of the ORI decrease, and a 1% decrease from the SpO2 value will be accepted as the beginning of the SpO2 decrease, and application times of FiO2 <60% will be recorded. FiO2 will be titrated by increasing or decreasing by 20% and the duration of FiO2 values equal to or <60% and FiO2 >60% will be recorded until the end of the operation.
Intervention code [1] 313192 0
Treatment: Devices
Comparator / control treatment
In the control group (Group C) patients will be followed up with continuous SpO2 measurement as standard. In the study group (Group O) continuous oxygen reserve index (ORI) monitoring together with perfusion index (PI) measurements in addition to SpO2 will be applied. ORI values will be monitored by Root® with Radical-7® (Masimo Corp., Irvine, CA, USA) device.
Control group
Active

Outcomes
Primary outcome [1] 308495 0
A 0.05 decrease in ORI. Root® with Radical-7® (Masimo Corp., Irvine, CA, USA) device will be used for the measurement.
Timepoint [1] 308495 0
Perioperative
Primary outcome [2] 334047 0
A 1% decrease in SpO2. Root® with Radical-7® (Masimo Corp., Irvine, CA, USA) device will be used for the measurement.
Timepoint [2] 334047 0
Perioperatively
Secondary outcome [1] 355149 0
Fractional inspired oxygen concentration (FiO2) >60% duration in minutes. This was recorded from the anesthesia machine monitor.
Timepoint [1] 355149 0
Perioperative

Eligibility
Key inclusion criteria
-8-18 year-old pediatric patients
-Elective minimally-invasive pectus excavatum repair surgery
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patient without consent
-Reoperation
-Emergency surgery
-Those with known serious respiratory or cardiac disease

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
Actual
1/03/2019
Sample size
Target
128
Accrual to date
Final
128
Recruitment outside Australia
Country [1] 21143 0
Turkey
State/province [1] 21143 0
Istanbul

Funding & Sponsors
Funding source category [1] 301490 0
University
Name [1] 301490 0
Marmara Üniversitesi Bilimsel Arastirma Projeler Birimi.
Country [1] 301490 0
Turkey
Primary sponsor type
Individual
Name
ayten saracoglu
Address
Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street , number:10, 34899 pendik/istanbul
Country
Turkey
Secondary sponsor category [1] 301185 0
None
Name [1] 301185 0
Address [1] 301185 0
Country [1] 301185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302234 0
Marmara University Medicine Faculty Ethics Committee
Ethics committee address [1] 302234 0
Basibuyuk neighborhood, number:2 , 34854 maltebe/ istanbul
Ethics committee country [1] 302234 0
Turkey
Date submitted for ethics approval [1] 302234 0
Approval date [1] 302234 0
02/02/2018
Ethics approval number [1] 302234 0

Summary
Brief summary
Measurement of oxygen reserve index with multi-wave pulse co-oximetry (Massimo, Ca, USA) is a noninvasive method. When the oxygen reserv index PaO2 is below 100 mmHg, it provides baseline level and additional data about the hypoxemia earlier than pulse oximetry. However, when SpO2 is greater than 98%, it guides the clinician related to hyperoxia. The primary hypothesis in this study is that Oxygen reserve index values can be used as an early predictor of hypoxemia caused by pneumothorax during Nuss surgery and may stimulate the clinician
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89534 0
Prof Ayten Saracoglu
Address 89534 0
Marmara university pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
fevzi cakmak Neighborhood, muhsin yazicioglu street , number:10, 34899 pendik/istanbul
Country 89534 0
Turkey
Phone 89534 0
+905377810144
Fax 89534 0
Email 89534 0
[email protected]
Contact person for public queries
Name 89535 0
A/Prof Ruslan Abdullayev
Address 89535 0
Marmara University Pendik Training and Research Hospital, Department of Anesthesiology and Reanimation, Fevzi Cakmak, Muhsin Yazicioglu Street, No:10, 34899, Pendik/Istanbul.
Country 89535 0
Turkey
Phone 89535 0
+905063010833
Fax 89535 0
Email 89535 0
[email protected]
Contact person for scientific queries
Name 89536 0
A/Prof Ruslan Abdullayev
Address 89536 0
Marmara University Pendik Training and Research Hospital, Department of Anesthesiology and Reanimation, Fevzi Cakmak, Muhsin Yazicioglu Street, No:10, 34899, Pendik/Istanbul.
Country 89536 0
Turkey
Phone 89536 0
+905063010833
Fax 89536 0
Email 89536 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
No additional documents have been identified.