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Trial registered on ANZCTR


Registration number
ACTRN12611001264976
Ethics application status
Approved
Date submitted
8/12/2011
Date registered
9/12/2011
Date last updated
9/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardio-respiratory effects of balancing Positive End Expiratory Pressure with intraabdominal pressures during laparoscopic cholecystectomy
Scientific title
Cardio-respiratory effects of balancing Positive End Expiratory Pressure with intraabdominal pressures during laparoscopic cholecystectomy
Secondary ID [1] 273560 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-respiratory effects (Heart rate, Mean arterial pressure, Cardiac output, Haemoglobin oxygen saturation, End tidal carbon dioxide concentration, Mean and peak airway pressure, Arterial blood gas analysis) 279360 0
Condition category
Condition code
Anaesthesiology 279530 279530 0 0
Other anaesthesiology
Metabolic and Endocrine 285553 285553 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positive End Expiratory Pressures of 5 and 10 cm H20 were applied using the ventilator in the Datex Omheda Anaesthesia Machine.
75 patients were randomly allocated to Group 0PEEP (n=25, PEEP 0), Group 5PEEP (n=25, PEEP 5) and Group 10PEEP (n=25, PEEP 10) according to level of PEEP in whom pneumoperitoneum was created with Intra Abdominal Pressures of 14, 8 and 14 mm Hg respectively.
Before creation of pneumoperitoneum 0, 5 and 10 cm H2O of PEEP was applied in 0PEEP, 5PEEP and 10PEEP groups respectively. The pneumoperitoneum was created by CO2 insufflation performed by the surgeon. IAP was set to be maintained at 14 mmHg by an automatic insufflator in 0PEEP and 10PEEP groups and 8 mm Hg in 5PEEP group. The PEEPs were applied upto 30 min of capnoperitonium.
Intervention code [1] 283856 0
Other interventions
Comparator / control treatment
Group 0PEEP, No Positive End Expiratory Pressure
Control group
Active

Outcomes
Primary outcome [1] 286110 0
Mean end tidal carbon dioxide concentration.
End-tidal carbon dioxide (ETCO2) were recorded using multiparameter monitor (Datex omheda side stream carbon dioxide analyser). Data were analyzed using Graphpad Instat 3.0, Graphpad software, San Diego, CA. Inter-group differences between the variables recorded were analyzed by repeated measures analysis of variance(ANOVA Test) followed by Bonferroni post hoc test of significance.
Timepoint [1] 286110 0
Preoperatively, 10 min postinduction, 5 min post PEEP, After Capnoperitonium 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min and 30 min.
Secondary outcome [1] 295141 0
Partial Pressure of arterial oxygenation as assessed using Arterial blood gas analysis
Timepoint [1] 295141 0
Preoperatively, at 5 minute after PEEP and 30 minute after capnoperitonium
Secondary outcome [2] 295142 0
Partial Pressure of arterial carbon dioxide as assessed using Arterial blood gas analysis
Timepoint [2] 295142 0
Preoperatively, at 5 minute after PEEP and 30 minute after capnoperitonium
Secondary outcome [3] 295143 0
Arterial PH as assessed using Arterial blood gas analysis
Timepoint [3] 295143 0
Preoperatively, at 5 minute after PEEP and 30 minute after capnoperitonium

Eligibility
Key inclusion criteria
All ASA I and II patients between the age group of 15-60 years scheduled to undergo elective laparoscopic cholecystectomy were recruited in the study after obtaining informed consent
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with pre-existing pulmonary disease, cardiovascular disease, neuromuscular disease and pregnant patients were excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
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)
Computarized 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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 3996 0
India
State/province [1] 3996 0
PUDUCHERRY

Funding & Sponsors
Funding source category [1] 284347 0
Self funded/Unfunded
Name [1] 284347 0
Dr Yamini Subramani
Country [1] 284347 0
India
Primary sponsor type
Individual
Name
Dr Yamini Subramani
Address
No E1 Alpha residency, Newstreet, Pudupet, Lawspet, Puducherry 605008
Country
India
Secondary sponsor category [1] 283285 0
None
Name [1] 283285 0
Address [1] 283285 0
Country [1] 283285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286292 0
JIPMER Institute Ethical committee
Ethics committee address [1] 286292 0
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER), Instutute of National Importance under Ministry of Health & Family Welfare, Governament of India, Dhanavantrinagar, PUDUCHERRY 605006
Ethics committee country [1] 286292 0
India
Date submitted for ethics approval [1] 286292 0
Approval date [1] 286292 0
30/07/2009
Ethics approval number [1] 286292 0
NO.DME/34/EC

Summary
Brief summary
Satisfactory conditions for creating a pneumoperitoneum are facilitated by the administration of neuromuscular blocking drugs to accommodate CO2 into a relaxed abdomen without a corresponding increase in intra-abdominal pressure (IAP). However, as the tone of diaphragm is lost due to neuromuscular paralysis, rising IAP pushes the diaphragm into the thoracic cavity resulting in loss of lung volume in its bases. Basal atelectasis together with higher CO2 load can compromise with CO2 elimination and result in hypercapnia. The authors hypothesize, that satisfactory CO2 elimination can be maintained if the lung volume is maintained with the similar amount of positive end expiratory pressure (PEEP) that can counter the rise in IAP.
The present study is designed to study the effect of PEEP similar to the IAP on gas exchange in patients undergoing laparoscopic cholecystectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33503 0
Address 33503 0
Country 33503 0
Phone 33503 0
Fax 33503 0
Email 33503 0
Contact person for public queries
Name 16750 0
Dr Yamini Subramani
Address 16750 0
Department of Anaesthesiology and critical care, JIPMER, Danvantari Nagar, Puducherry 605006
Country 16750 0
India
Phone 16750 0
91-0413-2252380
Fax 16750 0
91-0413- 22722067
Email 16750 0
[email protected]
Contact person for scientific queries
Name 7678 0
Dr Yamini Subramani
Address 7678 0
Department of Anaesthesiology and critical care, JIPMER, Danvantari Nagar, Puducherry 605006
Country 7678 0
India
Phone 7678 0
91-0413-2252380
Fax 7678 0
91-0413- 22722067
Email 7678 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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