Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000817943
Ethics application status
Approved
Date submitted
12/07/2011
Date registered
4/08/2011
Date last updated
4/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of inverse ratio pressure- controlled ventilation on the gas exchange in patients undergoing robot assisted prostatectomy
Scientific title
The effects of inverse ratio pressure- controlled ventilation on the gas exchange in patients undergoing robot assisted prostatectomy
Secondary ID [1] 262614 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 268310 0
robot-assisted prostatectomy 268311 0
Condition category
Condition code
Cancer 268438 268438 0 0
Prostate
Anaesthesiology 268439 268439 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be ventilated with tidal volume 7 ml/kg, inspiratory to expiratory ratio (I:E) of 1:2 in a pressure-controlled mode (PCM)(initial ventilation). After abdominal insufflations of CO2, mechanical ventilation by pressure-controlled mode (PCM) with 5 cmH2O PEEP and I:E of 2:1 will be applied to them during abdominal insufflation of carbon dioxide gas in Trendelenberg position (intervention). The inspiratory pressure will be set to deliver a tidal volume of 7 ml/kg during PCM. After desufflation of abdominal gas, the ventilation will returne to an initial ventilation method of PCM.
Intervention code [1] 266957 0
Treatment: Surgery
Intervention code [2] 266961 0
Treatment: Devices
Comparator / control treatment
Patients will be ventilated with tidal volume 7 ml/kg, inspiratory to expiratory ratio (I:E) of 1:2 in a pressure-controlled mode (PCM) , then after abdominal insufflations of CO2, mechanical ventilation by pressure-controlled mode (PCM) with 5 cmH2O PEEP and I:E of 1:2 will be applied to them during abdominal insufflation of carbon dioxide gas. The inspiratory pressure was set to deliver a tidal volume of 7 ml/kg during PCM. After desufflation of abdominal gas, the ventilation returned to an initial ventilation method of PCM.
Control group
Active

Outcomes
Primary outcome [1] 269191 0
airway pressures (peak and mean airway pressure and total PEEP) will be measured by continuous expiratory air sampling, using a mainstream sensor (CO2 SMO PLUS 8100, Novametrix Medical System Inc., Wallingford, CT) placed in-line between endotracheal tube and the Y-piece using S/5 monitor (Datex-Engstrom, Helsinki, Finland).
Timepoint [1] 269191 0
before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)
Primary outcome [2] 269192 0
Arterial blood gas analysis.
Timepoint [2] 269192 0
before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)
Primary outcome [3] 269358 0
lung compliance will be monitored by continuous expiratory air sampling, using a mainstream sensor (CO2 SMO PLUS 8100, Novametrix Medical System Inc., Wallingford, CT) placed in-line between endotracheal tube and the Y-piece using S/5 monitor (Datex-Engstrom, Helsinki, Finland).
Timepoint [3] 269358 0
before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)
Secondary outcome [1] 279096 0
radial arterial pressure (pulse wave analysis)
Timepoint [1] 279096 0
before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal insufflation of CO2 gas, and 20 min after return to basal ventilation with abdominal desufflation (Tend)
Secondary outcome [2] 279347 0
heart rate through electrocardiogram
Timepoint [2] 279347 0
before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal insufflation of CO2 gas, and 20 min after return to basal ventilation with abdominal desufflation (Tend)

Eligibility
Key inclusion criteria
American Society of Anesthesiologists physical status 1,2 patients undergoing elective robot-assisted prostatectomy
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
heart failure (defined as New York Heart Association classification more than 3), coronary artery disease, and obstructive pulmonary disease, defined as forced expiratory volume for 1 min below 80%

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 3706 0
Korea, Republic Of
State/province [1] 3706 0

Funding & Sponsors
Funding source category [1] 267423 0
Self funded/Unfunded
Name [1] 267423 0
jie ae kim
Country [1] 267423 0
Korea, Republic Of
Primary sponsor type
Individual
Name
jie ae kim
Address
Jie Ae Kim, M.D., Ph.D., Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country
Korea, Republic Of
Secondary sponsor category [1] 266474 0
None
Name [1] 266474 0
Address [1] 266474 0
Country [1] 266474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269395 0
Samsung Medical Centre Human Research Ethics Committee
Ethics committee address [1] 269395 0
Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Ethics committee country [1] 269395 0
Korea, Republic Of
Date submitted for ethics approval [1] 269395 0
25/04/2011
Approval date [1] 269395 0
02/06/2011
Ethics approval number [1] 269395 0
2011-04-014-001

Summary
Brief summary
In patients undergoing robot-assisted prostatectomy, positive end- expiratory pressure (PEEP) has been increasingly used to compensate decreased lung compliance. However, airway pressure is another obstacle to apply sufficient PEEP with adequate tidal volume. Prolongation of inspiration time with low level PEEP could provide additive alveolar recruitment effect avoiding increase in the peak airway pressure. This study intended to compare the gas exchange between conventional and inverse ratio ventilation in robot-assisted prostatectomy patients receiving mechanical ventilation by pressure-controlled mode (PCM).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32866 0
Address 32866 0
Country 32866 0
Phone 32866 0
Fax 32866 0
Email 32866 0
Contact person for public queries
Name 16113 0
jie ae kim
Address 16113 0
Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country 16113 0
Korea, Republic Of
Phone 16113 0
+82 2 3410 2470
Fax 16113 0
Email 16113 0
[email protected]
Contact person for scientific queries
Name 7041 0
jie ae kim
Address 7041 0
Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country 7041 0
Korea, Republic Of
Phone 7041 0
+82 2 3410 2470
Fax 7041 0
Email 7041 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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