Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000978662
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
11/09/2014
Date last updated
11/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of lung protective ventilatory strategy on systemic and pulmonary inflammatory responses during laparoscopic surgery: is it really helpful?
Scientific title
A prospective randomised trial to evaluate the effect of intraoperative tidal volume ventilation with 6ml/kg (Ideal Body weight) and positive end expiratory pressure (PEEP) of 8 cm H2O versus 12ml/kg (Ideal Body weight) on systemic and pulmonary inflammatory responses in adult patients undergoing laparoscopic surgery
Secondary ID [1] 285178 0
None
Universal Trial Number (UTN)
U1111-1160-3894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory stress in patients undergoing laparoscopic gynaecological surgery 292772 0
Condition category
Condition code
Anaesthesiology 293065 293065 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 ml/kg ventilation (according to ideal height and weight of the patients) and 0 cmH20 PEEP were performed to the patients in group I, 6 ml/kg ventilation (according to ideal height and weight of the patients) and 8 cmH20 PEEP were performed to the patients in group II patients continuously throughout laparoscopic surgery . The ideal body weight of patients was estimated with the formula as follows; 45.5 +/- 0.91 x (cm of height - 152.4)
To assess the systemic inflammatory responses, venous blood samples were taken via veni-puncture. To assess the pulmonary inflammatory responses of both groups, flexible bronchoscopy was performed through the endotracheal intubation tube and bronchoalveolar lavage (BAL) was obtained from right middle lobe or lingula. Second bronchoalveolar lavage was obtained from the contralateral lung (right middle lobe or left lingular segment).
Intervention code [1] 290162 0
Treatment: Devices
Comparator / control treatment
12ml/kg tidal volume and 0 cmH2O PEEP
Control group
Dose comparison

Outcomes
Primary outcome [1] 292933 0
inflammatory stress is measured by serum cytokine tumor necrosis factor-alpha, serum Interleukin-1, serum Interleukin 6 and serum Interleukin 8
Timepoint [1] 292933 0
within the first 5 minutes after endotracheal intubation (T1), 60 minutes after the initiation of mechanical ventilation (T2) and in the postanaesthesia care unit at 30 minute after tracheal extubation (T3)
Secondary outcome [1] 309976 0
inflammatory stress is measured by bronchoalveolar lavage cytokine tumor necrosis factor-alpha , bronchoalveolar lavage Interleukin-1 beta, bronchoalveolar lavage Interleukin 6 and bronchoalveolar lavage Interleukin 8
Timepoint [1] 309976 0
within the first 5 minutes after endotracheal intubation (T1)and in the postanaesthesia care unit at 30 minute after tracheal extubation (T3)

Eligibility
Key inclusion criteria
1-elective laparoscopic gynecological surgery
2- ASA 1-2 patients
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1-history of pulmonary diseases 2- thoracic surgery 3- immune deficiency 4-morbid obesity (body mass index greater than 35) 5-previous history of mechanical ventilation or surgical procedure during general anesthesia (lesser than one year)

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)
ASA 1-2 patients older than 18 years-old who were candidate for elective laparoscopic gynecological surgery were included in this study. All patients were informed and written informed consent was obtained from all the participants in the study. Sequentially-Numered,Opaque,Sealed Envelopes(SNOSE) were used as allocation concealment method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes that were maintained in opaque envelopes until the anesthesia began
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2012
Actual
12/07/2012
Date of last participant enrolment
Anticipated
Actual
28/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 6293 0
Turkey
State/province [1] 6293 0
Afyonkarahisar

Funding & Sponsors
Funding source category [1] 289787 0
University
Name [1] 289787 0
Afyon Kocatepe University
Country [1] 289787 0
Turkey
Primary sponsor type
University
Name
Afyon Kocatepe University
Address
No: 22 Izmir Road, Afyonkarahisar, 03200,Turkey
Country
Turkey
Secondary sponsor category [1] 288477 0
None
Name [1] 288477 0
Address [1] 288477 0
Country [1] 288477 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Laparoscopic surgery is performed by carbon dioxide (CO2) insufflation, but this may induce stress responses. The aim of this study is to compare the level of inflammatory mediators in patients receiving low-VT versus traditional-VT during gynecological laparoscopic surgery. Fourty ASA physical status 1 and 2 subjects older than 18 years-old undergoing laparoscopic gynecological surgery were included. Systemic and pulmonary inflammatory responses (IL6, TNF-alpha, IL8 and IL1B) of patients receiving intraoperative low-VT and traditional-VT during laparoscopic surgery were assessed in blood serum [within the first 5 minutes after endotracheal intubation (T1), 60 minutes after the initiation of mechanical ventilation (T2) and in the postanaesthesia care unit at 30 min after tracheal extubation (T3)] and bronchoalveolar lavage (BAL) within T1 and T3. Increase in the serum levels of IL6, TNF-alpha, IL8 and IL1B were observed in both groups during the time periods of T1, T2 and T3.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 50734 0
A/Prof Serdar Kokulu
Address 50734 0
Afyon Kocatepe University Faculty of Medicine,Department of Anaesthesiology and Reanimation, Izmir road Street No 22 Afyonkarahisar Postalcode: 03200
Country 50734 0
Turkey
Phone 50734 0
+905053918498
Fax 50734 0
Email 50734 0
[email protected]
Contact person for public queries
Name 50735 0
ELif Dogan Baki
Address 50735 0
Afyon Kocatepe University Faculty of Medicine,Department of Anaesthesiology and Reanimation,Izmir road Street No 22 Afyonkarahisar Postalcode: 03200
Country 50735 0
Turkey
Phone 50735 0
+905308739908
Fax 50735 0
Email 50735 0
[email protected]
Contact person for scientific queries
Name 50736 0
ELif Dogan Baki
Address 50736 0
Afyon Kocatepe University Faculty of Medicine,Department of Anaesthesiology and Reanimation, Izmir road street No 22 Afyonkarahisar Postalcode: 03200
Country 50736 0
Turkey
Phone 50736 0
+905308739908
Fax 50736 0
Email 50736 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.