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.: PACTR201808701148726 Date of Approval: 27/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pressure-controlled Ventilation could decrease Intraoperative Blood Loss and improve Airway pressure measures during Lumbar Discectomy in Prone Position: Comparative Study versus Volume-controlled Ventilation Mode
Official scientific title Pressure-controlled Ventilation could decrease Intraoperative Blood Loss and improve Airway pressure measures during Lumbar Discectomy in Prone Position: Comparative Study versus Volume-controlled Ventilation Mode
Brief summary describing the background and objectives of the trial Abstract Objectives: To observe the relation between volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes and changes of hemodynamic and airway pressure, and intraoperative (IO) blood loss during one-level lumbar discectomy performed in prone position Patients & Methods: VCV patients were using volume controlled mode for tidal volume (TV) of 8-10 ml/Kg without adjusting peak inspiratory pressure (PIP), but for PCV patients PIP was adjusted to provide volume calculated according to ideal body weight till achieving the same TV. Respiratory and hemodynamic parameters were recorded in supine (T1), on turning to prone (T2) and on returning to supine position (T3). Study outcomes included amount of IO blood loss, need for blood transfusion, intraoperative hemodynamic and airway pressure changes. Results: T2 heart rate and blood pressure were significantly reduced than T1 and T3 measures, with little impact of ventilation mode. Central venous pressure (CVP) measures were significantly higher at T1, 2 and 3 in VCV than PCV patients. Prone positioning resulted in significant increase of P-peak and non-significant decrease of P-mean pressure measures with VCV, while with PCV resulted in significantly increased airway pressures. P-peak pressure was significantly lower with PCV in supine and prone positions than VCV. P-mean pressure was significantly lower in supine, but was significantly higher in prone position with PCV than VCV. IO blood loss was significantly higher with VCV than PCV. CVP measures showed positive significant correlation with maintenance on VCV and with prone positioning and excess IO bleeding in both groups. Conclusion: Prone positioning deleteriously affected patients' hemodynamic and airway pressure parameters. PCV significantly improved airway pressures during prone and supine positions than VCV without affecting hemodynamic parameters. Prone positioning and VCV were associated with increased CVP and IO blood loss, while PCV could lessen these effects. Keywords: Ventilation Mode, Lumbar position, Intraoperative blood loss, Airway pressure measures
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/08/2018
Actual trial start date 26/08/2018
Anticipated date of last follow up 26/11/2018
Actual Last follow-up date 26/11/2018
Anticipated target sample size (number of participants) 92
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Volume controlled ventilation group throughout the whole procedure after intubation, mechanical ventilation was initiated with 100% oxygen using volume controlled mode (VCM) for a tidal volume (TV) of 8-10 ml/Kg and positive end-expiratory pressure (PEEP) at 5 cmH2O with the respiratory rate (RR) was set to maintain an end tidal CO2 (ETCO2) of 30-35 mmHg, without adjusting peak inspiratory pressure (PIP). 46
Control Group Pressure controlled ventilation group throughout the whole procedure PIP was adjusted for a flow rate to provide volume calculated according to IBW to achieve TV of 8-10 ml/kg with PEEP at 5 cmH2O. 46 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients assigned for lumbar discectomy and were of ASA grade I or II were enrolled in the study Exclusion criteria included emergency cases, obesity with body mass index > 30 kg/m2, expected difficult intubation, multiple level lumbar disc prolapse, previous chest surgery, restrictive pulmonary diseases, bleeding diathesis, presence of asthmatic bronchitis, or cardiac, hepatic or renal compromise, allergy to anesthetics or drugs planed to be used. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 23/08/2018 Faculty of medicine Aswan university
Ethics Committee Address
Street address City Postal code Country
El seel street Aswan EGYPT Aswan 331111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Primary outcome included amount of intraoperative (IO) blood loss, calculated as the sum of the amount of blood collected in the suction canister and the calculated net weight of gauze swabs. Blood transfusion was indicated if hematocrit value dropped to <30%; the frequency of patients required blood transfusion and number of transfused units was recorded. throughtout the whole procedure
Secondary Outcome - Secondary outcome included operative time, intraoperative changes of HR, blood pressure measures and CVP and airway pressure measures including P-peak and P-mean. throughtout the whole procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Aswan university El seel street Aswan 331111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir Abu zikary EL Sayed Banha Egypt Banha 333257 Egypt Individual
Secondary Sponsor Sherif kamal arafa Tanta Gharbia Egypt Tanta 333257 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Sherif kamal Arafa Egypt Gharbia tanta 12 tout angh street Gharbia 333257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Amir Abu Zikary El Sayed aabozikry@yahoo.com 00201016326544 Egypt / Bamha / 10 el gaish street
City Postal code Country Position/Affiliation
Banha 333257 Egypt lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 00201227744329 Egypt / Gharbia / Tanta 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 333257 Egypt lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com 00201227744329 Egypt / Gharbia / Tanta 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 333257 Egypt lecturer of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information