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.: PACTR202204835139290 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title two modes of mechanical ventilation during cardiac surgery.
Official scientific title RESPIRATORY EFFECTS OF TWO MODES OF VENTILATION DURING CARDIAC SURGERY.
Brief summary describing the background and objectives of the trial Postoperative pulmonary complications after cardiac surgeries are frequent with an incidence of 50%. These complications are associated with prolonged ICU and hospital stay which increase the healthcare cost. There are many pulmonary complications that might happen after cardiac surgeries but atelectasis and pleural effusion are the most common. Atelectasis happens because of intraoperative and postoperative causes. These intraoperative causes include general anesthesia induction, manual compression by the surgeon during left internal mammary artery harvesting and cannulation of IVC, and apnea during cardiopulmonary bypass time. Mechanical ventilation is a must during cardiac surgeries even during off-pump coronary artery bypass surgery. There are different modes of ventilation but the volume-controlled (VCV) mode is the most widely used mode of ventilation. VCV is delivering more or less the preset Tidal volume (TV) and the preset respiratory rate (RR) associated with increased peak inspiratory pressure and increased risk of volutrauma and barotrauma. Pressure regulated volume control mode (PRVC) is a new mode of ventilation that gathers the advantage of VCV of delivering adequate TV and the advantage of pressure-controlled ventilation (PCV) of decreasing the peak and the plateau airway pressures. It is characterized by a decelerating flow that can achieve proper alveolar ventilation and oxygenation. PRVC mode is calculating the lung compliance after each breath and delivers the preset TV with the lowest possible inspiratory pressure. The aim of this prospective randomized study is to compare the effects of PRVC and VCV on oxygenation (measured by oxygenation index, OI) as the primary outcome and on respiratory dynamics as the secondary outcome. We hypothesize that PRVC will be associated with a better oxygenation index and respiratory dynamics.
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 Treatment: Devices
Anticipated trial start date 15/05/2022
Actual trial start date
Anticipated date of last follow up 15/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group P inspiratory pressure will be kept to deliver the preset TV and to maintain the following ventilation parameters: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. inspiratory pressure will be kept to deliver the preset TV and to maintain the following ventilation parameters: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. inspiratory pressure will be kept to deliver the preset TV and to maintain the following ventilation parameters: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. 31
Control Group group V ventilation will be maintained like the following: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. ventilation will be maintained like the following: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. ventilation will be maintained like the following: TV: 6ml/kg (ideal body weight). RR: 12/minute (will be changed to keep EtCO2 at 30-35mmHg). FiO2: 50% PEEP: 5 cmH2O (will be removed after opening the chest wall). until the skin is closed. 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. both sex, 2. age more than 20 years old, 3. candidates for elective on-pump cardiac surgery. 1. Patients for emergency cardiac surgery, 2. redo cardiac surgery, 3. with known pulmonary diseases, 4. morbid obesity with a BMI of more than 35%, 5. renal failure, 6. heart failure EF less than 40% 7.patient refusal Adult: 19 Year-44 Year 20 Year(s) 80 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 22/03/2022 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
60 Elgomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the effects of PRVC and VCV on the oxygenation (measured by oxygenation index, OI). room air, after intubation, 5 minutes before and after bypass and 15 minutes after bypass
Secondary Outcome peak airway pressure (Ppeak), plateau airway pressure (P plat), mean airway pressure(Pmean), and lung compliance 10 minutes after intubation, 5 minutes before and after bypass and 15 minutes after bypass
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cardiothoracic and vascular surgery center 60 Elgomhoria street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsayed Mohamed Hassan Abdelkarime 60 Elgomhoria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine 60 Elgomhoria street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Amin Eissa 60 Elgomhoria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Abdelkarime elsayedabdelkarime@mans.edu.eg 0096567685097 Qutaiba street
City Postal code Country Position/Affiliation
kuwait 030000 Kuwait lecturer of anesthesia and ICU Faculty of medicine Mansoura university.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Eissa drah.amin@mans.edu.eg 00201009609062 60 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of anesthesia and ICU Faculty of medicine Mansoura university.
Role Name Email Phone Street address
Public Enquiries may Badr mayelsherbiny@mans.edu.eg 00201007193959 60 Elgomhoria st
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of anesthesia and ICU faculty of medicine Mansoura university.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared Informed Consent Form,Statistical Analysis Plan,Study Protocol will be shared after the publishing of the paper and no end time. data will be open to the investigator who is doing a study related to the topic of the present trial. it can be approached through my research gate account with the name (Elsayed Abdelkarime).
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