Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001388104 Date of Approval: 13/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between pressure regulated volume-controlled (PRVC) and volume-controlled (VC) ventilation on oxygenation parameters, airway pressures and
Official scientific title Comparison between pressure regulated volume-controlled (PRVC) and volume-controlled (VC) ventilation on oxygenation parameters, airway pressures and immune-modulation during thoracic surgery.
Brief summary describing the background and objectives of the trial One lung ventilation (OLV) during thoracic surgery may potentially trigger alveolar cell damage and release of pro-inflammatory mediators that might affect postoperative outcome. The current trial is planned to evaluate effect of two different ventilatory strategies: Pressure regulated volume-controlled (PRVC) versus volume-controlled (VC) ventilation on oxygenation parameters, airway pressures and hemodynamics, in addition to alveolar and systemic immune-modulation during thoracic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied One lung ventilation during thoracic surgery,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/12/2015
Actual trial start date
Anticipated date of last follow up 20/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRVC group All patients will be ventilated with a tidal volume (VT) of 10 ml/kg during two-lung ventilation (TLV) before surgery and reduced to 6 ml/kg during OLV in association with 10 cmH2O PEEP All patients will be ventilated with a tidal volume (VT) of 10 ml/kg during two-lung ventilation (TLV) before surgery and reduced to 6 ml/kg during OLV in association with 10 cmH2O positive end-expiratory pressure (PEEP) throughout surgery. Then, VT will be set back to 10 ml/kg after return to TLV. Fraction of inspired oxygen (FIO2) of 0.60% in air will be used during TLV and changed to 0.8 to 1.0 25
Experimental Group VC group All patients will be ventilated with a tidal volume (VT) of 10 ml/kg during two-lung ventilation (TLV) before surgery and reduced to 6 ml/kg during OLV in association with 10 cmH2O PEEP All patients will be ventilated with a tidal volume (VT) of 10 ml/kg during two-lung ventilation (TLV) before surgery and reduced to 6 ml/kg during OLV in association with 10 cmH2O positive end-expiratory pressure (PEEP) throughout surgery. Then, VT will be set back to 10 ml/kg after return to TLV. Fraction of inspired oxygen (FIO2) of 0.60% in air will be used during TLV and changed to 0.8 to 1.0 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients ASA I-III undergoing elective open thoracic surgery using one lung ventilation. Preoperative exclusion criteria will include patient refusal, significant lung diseases {forced expiratory volume in 1 s (FEV1) or vital capacity (VC) < 50% of the predicted values}, uncompensated cardiac disease or mean pulmonary artery pressure (MPAP) > 30 mm Hg, hepatic or renal disease, coagulation disorders or a history of pre-operative immuno-suppressant medications. Intraoperative exclusion criteria will include inability to maintain an appropriate arterial oxygen saturation(SpO2) and end-tidal carbon dioxide (EtCO2), inability to keep stable mechanical ventilation settings for 30 min, , abnormal surgical complications, and prolonged hemodynamic instability 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/12/2015 Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome arterial, and central venous blood gases, Pa O2/FIO2 ratio, dead space volume/tidal volume (VD/VT) ratio, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), and plateau inspiratory pressure (Plateau), obtained at four different time points: 20 min after TLV (T0), 20 min after one lung ventilation (T1), 20 min after return to TLV (T2) and at end of surgery (T3).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Khaled M Mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information