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.: PACTR202401894086611 Date of Approval: 26/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post-operative neurally adjusted ventilatory assisted ventilation for weaning of hepatic patients
Official scientific title Post-operative neurally adjusted ventilatory assisted ventilation compared to pressure support for weaning of hepatic patients undergoing major abdominal surgeries
Brief summary describing the background and objectives of the trial Postoperative care for hepatic patients undergoing major abdominal surgeries can include mechanical ventilation in the intensive care unit (ICU),Prolonged MV is associated with a host of complications (e.g. infection, gastrointestinal bleeding, and deep venous thrombosis). On the other hand, premature extubation followed by re-intubation is associated with increased morbidity and mortality. Choosing the right time for a successful discontinuation of MV remains a challenge.Fatigue of patients undergoing weaning from MV is a major factor in failure to wean. so our objectives 1- assess the effectiveness of Neurally adjusted ventilatory assist (NAVA) as a ventilatory mode that tailors the level of assistance delivered by the ventilator to the electromyographic activity of the diaphragm. 2- have a role to improve gas exchange and restore breathing variability
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NAVA
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 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 01/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Pressure control ventilation ventilator mode adjusted to the patient postoperative Post-operative weaning of hepatic patients undergoing major abdominal surgeries using PSV. 60 Placebo
Experimental Group neurally adjusted vantilatory assissted the amount of pressure delivered (in cmH2O) adjusted by multiplying the Edi (expressed in μV) by a proportionality factor, known as the “NAVA level” (expressed in cmH2O/μV). postoperative the amount of pressure delivered (in cmH2O) adjusted by multiplying the Edi (expressed in μV) by a proportionality factor, known as the “NAVA level” (expressed in cmH2O/μV). 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age: adults above 18 years old. 2- Hepatic patients (Child pugh A and B) undergoing major abdominal surgeries (e.g. hepatic resections, Whipple operation, etc.) requiring post-operative mechanical ventilation. • Parent’s refusal. • Contraindication to placement of the NAVA esophageal tube (i.e. any contraindication to placement of a gastric tube, recent gastrointestinal suture, rupture of esophageal varices with gastrointestinal bleeding during the 4 days prior to inclusion or esophageal malformation. • Hepatic patients (Child pugh C) • Severely debilitated patient. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 01/03/2020 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV) regarding: asynchrony index. Postoperative after patient transportation and stabilization in ICU and after 2,6,12,18 and 24 hours in the ICU
Secondary Outcome duration of mechanical ventilation, ventilator‑free days, application and duration of post-extubation noninvasive mechanical ventilation, ICU and hospital length of stay and cost. Postoperative after patient transportation and stabilization in ICU and after 2,6,12,18 and 24 hours in the ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rasha Foaad Metawe Elshoney hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstent lecture of anasthesia
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Scientific Enquiries rasha Foaad Metawe Elshoney hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstent lecture of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data will be shared patient and method , study protocol ,the results,summary and the full paper when puplished in international anasthesia journal Informed Consent Form,Statistical Analysis Plan,Study Protocol when result will be available neurally adjusted ventilatory assessed weaning
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia journal 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