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.: PACTR201606001629302 Date of Approval: 11/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effects of Inverse Ratio Ventilation on Pulmonary Functions
Official scientific title The Effects of Inverse Ratio Ventilation on Pulmonary Functions
Brief summary describing the background and objectives of the trial Laparoscopy is associated with increases peak airway pressure (Ppeak) and high end-tidal carbon dioxide tension (PETCO2) with conventional ratio ventilation mode, especially in obese patients(3,4). It is difficult to improve the hypercapnia by increasing the respiratory rate or tidal volume, as the high airway pressure may not allow a further increase in tidal volume, and increasing respiratory rate sometimes fails to correct hypercapnia. Applying positive endexpiratory pressure (PEEP) might improve oxygenation and be accompanied with an increase in Ppeak. Furthermore, high tidal volume and high airway pressure may lead to lung barotrauma and volutrauma(5,6). Conventional inspiratory to expiratory (I/E) ratio is 1:2. Prolonged I/E ratio ventilation, for example 1:1 or 2:1, was used to improve arterial oxygenation in patients with lung injury(5). In this study, we will investigate whether volume-controlled IRV (I:E= 2:1) will be superior to conventional ratio ventilation in terms of Oxygenation, respiratory mechanics and cardiac output in obese patients undergoing laparoscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2016
Actual trial start date 01/04/2016
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL 30882/04/16
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 ¿Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group (I) Group (I): will receive conventional ratio ventilation (I:E= 1:2). after inssuflation of pneumopertoeum till the end of the procedure After entering the operating room, monitoring, including electrocardiogram, noninvasive blood pressure, heart rate and pulse oximetry will be applied and venous access will be established. After preoxygenation, anesthesia will be induced with intravenous fentanyl 2µg/kg, propofol 2 mg/kg given, and cis-atracurium 0.15 mg/kg. Then tracheal intubation will be established. Arterial cannula will be in 30 Active-Treatment of Control Group
Control Group group (I) Group (I): will receive conventional ratio ventilation (I:E= 1:2). after inssuflation of pneumopertoeum till the end of the procedure After entering the operating room, monitoring, including electrocardiogram, noninvasive blood pressure, heart rate and pulse oximetry will be applied and venous access will be established. After preoxygenation, anesthesia will be induced with intravenous fentanyl 2µg/kg, propofol 2 mg/kg given, and cis-atracurium 0.15 mg/kg. Then tracheal intubation will be established. Arterial cannula will be in 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with of ASA physical status II, aged ¿ 18 years, and with a body mass index (BMI) of ¿40 kg/m2 will be included. Patients with a history of uncontrolled respiratory/ cardiovascular morbidity or cerebrovascular disease will be excluded. 18 Year(s) 55 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 01/04/2016 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome In this study, we will investigate whether volume-controlled IRV immediately before onset of pneumoperitoneum (T1), 60 minutes after onset of pneumoperitoneum (T2), and the end of surgery (T3). Arterial blood gas will be analyzed
Secondary Outcome to investigate if inverse ratio ventilation effect on cardia output Then tranceducer of transoesphageal Doppler will be inserted. The cardiac index and the oxgen delivery index will be monitored in both groups immediately before onset of pneumoperitoneum (T1), 60 minutes after onset of pneumoperitoneum (T2), and the end of surgery (T3).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals elgeish street tanta 5555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine 1 elgeish street tanta 1111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesiology department elgeish street tanta 3344 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
gehan morsy eid 7 thrwat street tanta 1147 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 thrwat street
City Postal code Country Position/Affiliation
tanta 1147 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Public Enquiries mohammed abo el yazed mohd_yazed75@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta 7788 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Scientific Enquiries gehan eid gehan2552011@gmail.com 01287466651 7th tharwat street
City Postal code Country Position/Affiliation
tanta Egypt Lecturer of Anaesthesia and and Intesive care
REPORTING
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