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.: PACTR202112653971335 Date of Approval: 07/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of pressure targeted modes of ventilation on diaphragmatic function as assessed using ultrasonography in critically ill patients with cerebral insult
Official scientific title Impact of pressure targeted modes of ventilation on diaphragmatic function as assessed using ultrasonography in critically ill patients with cerebral insult
Brief summary describing the background and objectives of the trial Assessment of & comparison between the pressure targeted modes of ventilation regarding their influence on diaphragmatic function as assessed using ultrasonography in critically ill patients with cerebral insult.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 10/02/2020
Actual trial start date 01/03/2020
Anticipated date of last follow up 07/03/2021
Actual Last follow-up date 11/04/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Diaphragmatic function as asssessed using ultrasonography in Pressure support ventilation mode. on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 72 hrs. measurement of diaphragmatic excursion and thickness using ultrasonography in Pressure support ventilation mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 15 Uncontrolled
Experimental Group Diaphragmatic function as assessed using ultrasonography in Assist Control Pressure controlled mode. on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 72 hrs. measurement of diaphragmatic excursion and thickness using ultrasonography in Assist Control Pressure controlled ventilation mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 15
Experimental Group Diaphragmatic function as asssessed using ultrasound in Synchronized Intermittent Mandatory mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 72 hrs measurement of diaphragmatic excursion and thickness using ultrasonography in Synchronized Intermittent Mandatory Ventilation Pressure Controlled ventilation mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 15
Experimental Group Diaphragmatic function as assessed using ultrasound in Bilevel Positive Airway Pressure mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 72 hrs measurement of diaphragmatic excursion and thickness using ultrasonography in Bi-level Positive Airway Pressure ventilation mode on ICU admission, 24 and 72 hrs (T1, T2 and T3 respectively). 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients age ≥ 21 years. • Both genders. • Mechanically ventilated patients due to primary cerebral insult (ischemic or hemorrhagic or embolic incident) or secondary to traumatic brain injury in ER or OR. • Eligible for proposed pressure targeted modes of mechanical ventilation. • Afebrile. • Hemodynamically stable patients or with minimal doses of vasopressors or inotropes. • Minimal doses of sedation if needed. • Refusal of the legal guardians to the intervention or participation of the patient in the study. • Use of Neuromuscular blockers. • Patient < 21 years old. • Diaphragmatic dysfunction on ICU admission. • History of Diaphragmatic palsy or Diaphragmatic hernia. • History of brainstem injury or cervical spine injury or neuromuscular disease. • Severe Hemodynamically unstable patients. • Presence of ascites or colonic distention or any mechanical factor in the chest or abdomen interfering with diaphragmatic mobility. • Presence of chest deformities or pneumothorax or pneumomediastinum or pleurodesis or moderate to severe pleural effusion or surgical emphysema in the chest. • Rhabdomyolsis. • Cachectic and malnourished patients. • Pregnancy. • Psychiatric illness. • Patients with chronic pulmonary disease or respiratory failure. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 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 09/02/2020 Faculty of Medicine Research Ethics Comittee REC
Ethics Committee Address
Street address City Postal code Country
Abassayia, cairo cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Diaphragmatic motion in terms of Diaphragmatic Excursion (DE) during spontaneous breathing trails. 2. Diaphragmatic thickness in terms of Diaphragmatic Thickness Fraction (DTF). zero, 24, 72 hrs
Secondary Outcome 1. Total duration of ventilation. 2. Length of ICU stay. 72 hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospital El-Khalifa El-Maamoun, Abbassyia cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hadeer Mosadek Hassan El Maamoun street cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Ain Shams university hospital El-Khalifa El-Maamoun, Abbasyia cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Mohamed Kamal Dr_Medo2000@hotmail.com +201003787898 Abbasyia
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Raham Hasan Mostafa ElOwaidy rahamhasan@yahoo.com +201222530020 Abbasyia
City Postal code Country Position/Affiliation
cairo 11566 Egypt Assistant Professor
Role Name Email Phone Street address
Principal Investigator Amr Mohamd El Said Kamel amrsaid_9@hotmail.com +201099662413 Abbasyia
City Postal code Country Position/Affiliation
cairo 11566 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data was collected during the trial, after deidentification Study Protocol begining 3 months and ending 2 years following article publication Researchers who provide a methodological sound proposal.
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