Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001167651
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
6/11/2014
Date last updated
6/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pressure-controlled ventilation and volume-controlled ventilation effects on pulmonary mechanics and inflammatory markers in prone position in patients undergoing elective spinal surgery
Scientific title
Comparing the effect of pressure-controlled ventilation and volume-controlled ventilation on pulmonary mechanics and inflammatory markers in prone position in patients undergoing elective spinal surgery
Secondary ID [1] 283883 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal surgery
 290869 0
prone surgery 291071 0
pulmonary mechanics 293046 0
Condition category
Condition code
Anaesthesiology 291227 291227 0 0
Other anaesthesiology
Surgery 293407 293407 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The heart rates (3-channel electrocardiograms), noninvasive blood pressure and peripheral oxygen saturation (SpO2) of all the patients were monitored. After anesthesia induction (propofol 2mg/kg , midazolam 1mg fentanyl 2mcg/kg rocuronium 1mg/kg) a 20 G catheter placed radial artery. Patients grouped random. First group selected as volume controlled ventilation, second group selected pressure controlled ventilation. Volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) are not different ventilatory modes, but are different control variables within a mode. Just as the debate over the optimal ventilatory mode continues, so too does the debate over the optimal control variable. VCV offers the safety of a pre-set tidal volume and minute ventilation but requires the clinician to appropriately set the inspiratory flow, flow waveform, and inspiratory time. During VCV, airway pressure increases in response to reduced compliance, increased resistance, or active exhalation and may increase the risk of ventilator-induced lung injury. PCV, by design, limits the maximum airway pressure delivered to the lung, but may result in variable tidal and minute volume. During PCV the clinician should titrate the inspiratory pressure to the measured tidal volume, but the inspiratory flow and flow waveform are determined by the ventilator as it attempts to maintain a square inspiratory pressure profile. frequency of ventilation measured by end tidal carbondioxide. we aimed 35-45 mmHg end tidal carbondioxide. we ventilated all patients from entubation to extubation.
Intervention code [1] 288557 0
Treatment: Devices
Comparator / control treatment
this study is based on comparing two different ventilation techniques. Volume controlled ventilation is compared pressure controlled ventilation
Control group
Active

Outcomes
Primary outcome [1] 291221 0
inflammatory markers (IL-6 , IL-8) are assessed. these markers are measured by immunoassay.
Timepoint [1] 291221 0
inflammatory markers were recorded 0. hour, 6. hour, 12. hour
Primary outcome [2] 291222 0
pulmonary mechanics such as supine/prone ppeak, supine/prone dynamic compliance, supine/prone peak, supine/prone minute volume, ETCO2, respiration rate are recorded by GE carescape monitor b650 and datex ohmeda avance s/5
Timepoint [2] 291222 0
pulmonary mechanics were recorded durring operation every 5 minutes
Secondary outcome [1] 306268 0
non invasive blood pressure
Timepoint [1] 306268 0
values were recorded during the preoperative period, after the induction of general anaesthesia until the end of surgery 5 min intervals
Secondary outcome [2] 306269 0
spo2
Timepoint [2] 306269 0
Sp02 values were recorded during the preoperative period and after the induction of general anaesthesia until the end of surgery at 5 minute intervals. these outcomes were assessed by pulse oximetry recorded by GE carescape monitor b650.

Eligibility
Key inclusion criteria
1-American Society of Anesthesiologists (ASA) risk scores of I–III

2- Patients were scheduled to undergo elective spinal surgery
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- American Society of Anesthesiologists (ASA) risk scores of IV -V

2- patiens who had immunologic disease

3- pregnancy, cancer

Study design
Purpose of the study
Treatment
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
Recruiting
Date of first participant enrolment
Anticipated
15/01/2014
Actual
25/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5733 0
Turkey
State/province [1] 5733 0
afyonkarahisar/central

Funding & Sponsors
Funding source category [1] 288526 0
University
Name [1] 288526 0
Afyon Kocatepe University Scientific Commission Research Unit
Country [1] 288526 0
Turkey
Primary sponsor type
University
Name
Afyon Kocatepe University Scientific Commission Research Unit
Address
Afyon Kocatepe University Medicine Facility afyon- izmir highway 8.km central / afyonkarahisar post code:03100
Country
Turkey
Secondary sponsor category [1] 287236 0
None
Name [1] 287236 0
Address [1] 287236 0
Country [1] 287236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290388 0
Afyon Kocatepe University Medicine Facility Committee of Clinical Investigations
Ethics committee address [1] 290388 0
Afyon Kocatepe University Medicine Facility afyon izmir highway 8. km central / afyonkarahisar post code:03100
Ethics committee country [1] 290388 0
Turkey
Date submitted for ethics approval [1] 290388 0
Approval date [1] 290388 0
26/12/2013
Ethics approval number [1] 290388 0

Summary
Brief summary
Material and Method: Forty patients aged between 20 and 80 years with American Society of Anesthesiologists (ASA) risk scores of I–III scheduled to undergo elective spinal surgery were included in the study. Randomization was achieved with sealed envelops containing randomisation numbers (simple randomisation using a randomisation table from a statistic book).
Before general anaesthesia, one group was set volume controlled ventilation, and the other group was set pressure controlled ventilation. Heart pressure, SPO2, pulmonary mechanics(supine/prone ppeak, supine/prone dynamic compliance, supine/prone peak, supine/prone minute volume, End tidal carbondioxide, respiration rate) recorded and blood samples are taken for inflammatory markers (Interleukin-6, Interleukin-8) . We took blood samples at 0. Hour 6. Hour and 12. Hour for inflammatory markers.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 45442 0
Dr hasan senay
Address 45442 0
afyon kocatepe universty medicine facility afyon-izmir highway 8.km Anesthesiology and Reanimation Department, central / afyonkarahisar post code:03100 AFYONKARAHISAR
Country 45442 0
Turkey
Phone 45442 0
+905055078822
Fax 45442 0
Email 45442 0
[email protected]
Contact person for public queries
Name 45443 0
hasan senay
Address 45443 0
afyon kocatepe universty medicine facility afyon-izmir highway 8.km Anesthesiology and Reanimation Department, central / afyonkarahisar post code:03100 AFYONKARAHISAR
Country 45443 0
Turkey
Phone 45443 0
+905055078822
Fax 45443 0
Email 45443 0
[email protected]
Contact person for scientific queries
Name 45444 0
hasan senay
Address 45444 0
afyon kocatepe universty medicine facility afyon-izmir highway 8.km Anesthesiology and Reanimation Department, central / afyonkarahisar post code:03100 AFYONKARAHISAR
Country 45444 0
Turkey
Phone 45444 0
+905055078822
Fax 45444 0
Email 45444 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

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

Documents added automatically
No additional documents have been identified.