Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000625471
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
13/05/2016
Date last updated
13/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of spontaneous ventilation with mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia;
Scientific title
The effect of spontaneous ventilation with venturi mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia; a randomized controlled study
Secondary ID [1] 286391 0
none
Universal Trial Number (UTN)
U1111-1168-3483
Trial acronym
VMTOCSSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
otherwise healthy parturients planned for cesarean section 297294 0
Condition category
Condition code
Anaesthesiology 297733 297733 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will randomized with the closed envelope method.

All patients will be monitored and the basal vital functions (HR, SpO2, NIBP and StO2) will be recorded with admission into the OR.

All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach, at a level of L3-L4, with a 25 G Quincke type spinal needle and 2.5 ml hyperbaric bupivacaine.

After succesful administration of anesthesia, all patients will be placed into supine position, monitored and administered oxygene via a venturi mask after administration of spinal anesthesia until the completion of surgery in different inspirated fractions (31%, 40% and 60%) and all vital functions will be recorded (HR, SpO2, NIBP and StO2) after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively

Beside this, hemoglobin levels will be evaluated preoperatively, during surgery and postoperatively in the 30th and 60th minute, by a noninvasive continuous monitoring device.

Spinal block levels, duration of surgery, APGAR scores, vasopressor consumption will be recorded.
Intervention code [1] 291460 0
Prevention
Comparator / control treatment
patients will allocate to three group

first group: breathe 31% oxygen group (n=30) (CONTROL GROUP)
second group: breath 40% oxygen group (n=30)
third group: breath 60% oxygen group (n=30)
Control group
Dose comparison

Outcomes
Primary outcome [1] 294609 0
The impact of different inspiratory fractions of oxygene on tissue oxygenation assessed by the InSpectra tissue spectrometer (Hutchinson technology, Hutchinson, MN, USA) is the primary goal of the study.
Timepoint [1] 294609 0
StO2 will be assessed at admission to OR, after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively.
Secondary outcome [1] 313711 0
The impact of different inspiratory fractions of oxygen on pediatric APGAR scores which will be evaluated in the OR after delivery by a pediatrist.
Timepoint [1] 313711 0
APGAR scores in 1 minute and 5 minutes after delivery

Eligibility
Key inclusion criteria
ASA physical status I–II term parturients
undergoing elective CS under spinal anesthesia
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
ASA status; > II
Coexisting disease; metabolic, endocrine, hepatic, cardiac or renal diseases, malignancies, preeclampsia; hypertension;
Concurrent medication used; or recent use (within 48h) of any drug with anti-oxidant properties such as nebivolol, carvedilol, vitamins E and C, or acetylcysteine

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
29/04/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6767 0
Turkey
State/province [1] 6767 0
SANLIURFA

Funding & Sponsors
Funding source category [1] 292691 0
University
Name [1] 292691 0
Harran University
Country [1] 292691 0
Turkey
Primary sponsor type
Hospital
Name
Harran University School of Medicine, Research and Training Hospital
Address
Harran University School of Medicine, Research and Training Hospital.

Meteoroloji ROAD, 101.STREET, Post code: 63100,
HALILIYE, SANLIURFA, TURKEY
Country
Turkey
Secondary sponsor category [1] 291570 0
None
Name [1] 291570 0
Address [1] 291570 0
Country [1] 291570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294222 0
Harran university medical faculty ethics committe
Ethics committee address [1] 294222 0
Harran University medical school yenisehir campus 63300 sanliurfa/Turkey
Ethics committee country [1] 294222 0
Turkey
Date submitted for ethics approval [1] 294222 0
12/02/2015
Approval date [1] 294222 0
13/02/2015
Ethics approval number [1] 294222 0
74059997.050.01.04/045

Summary
Brief summary
During spinal, changes in respiratory function occur and resulting in impaired maternal-foetal gas exchange so that oxygen supplementation is commonly given to prevent maternal oxyhaemoglobin desaturation and to optimize fetal oxygenation. Changes in lung capacity, the mother and the fetus also causes decreased oxygen delivery to both uteroplacental hypoperfusion and fetal distress. However, the optimal maternal and intrauterine foetal arterial oxygen content before delivery during a routine caesarean section is not known. Many pregnant women are empirically given supplemental oxygen intraoperatively at least until the delivery of the baby. In addition, oxygen is a potentially toxic substance and could conceivably present a risk to both fetus and mother. For these reasons, it is important to establish whether health benefits may be derived from the use of oxygen for this purpose. We aimed to investigate the effect of 31%, 40% and 60% oxygen supplementation on maternal tissue oxygenation in elective cesarean section (CS) under spinal anesthesia.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 727 727 0 0
/AnzctrAttachments/368085-ETI?K KURUL-1.pdf
Attachments [2] 728 728 0 0
/AnzctrAttachments/368085-ETI?K KURUL-2.pdf
Attachments [3] 729 729 0 0
/AnzctrAttachments/368085-clinical record form.doc

Contacts
Principal investigator
Name 55398 0
A/Prof Mahmut Alp Karahan
Address 55398 0
Harran university medical faculty research and training hospital 63100 Haliliye sanliurfa TURKEY
Country 55398 0
Turkey
Phone 55398 0
+905327808997
Fax 55398 0
Email 55398 0
[email protected]
Contact person for public queries
Name 55399 0
A/Prof Mahmut Alp Karahan
Address 55399 0
Harran university medical faculty research and training hospital 63100 Haliliye sanliurfa TURKEY
Country 55399 0
Turkey
Phone 55399 0
+905327808997
Fax 55399 0
Email 55399 0
[email protected]
Contact person for scientific queries
Name 55400 0
A/Prof mahmut alp karahan
Address 55400 0
Harran university medical faculty research and training hospital 63100 Haliliye sanliurfa TURKEY
Country 55400 0
Turkey
Phone 55400 0
+905327808997
Fax 55400 0
Email 55400 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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