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.: PACTR201909817075549 Date of Approval: 02/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Manual Hyperinflation in Supine Versus Lateral Decubitus Position in Ventilator Associated Pneumonia
Official scientific title Efficacy of Manual Hyperinflation in Supine Versus Lateral Decubitus Position in Ventilator Associated Pneumonia
Brief summary describing the background and objectives of the trial One of the more difficult ventilator problems confronting physicians in the critical care unit is the management of patients who have unilateral lung disease (ULD) as ventilator associated pneumonia (VAP). This study was conducted to compare the efficacy of manual hyperinflation (MHI) in supine versus lateral decubitus position on Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Oxygen saturation (SaO2) and ratio of partial pressure of oxygen and fraction inspired oxygen (PaO2/FiO2). in those patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied pneumonia
Purpose of the trial Rehabilitation
Anticipated trial start date 01/08/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date 31/03/2018
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group manual hyperinflation from supine lying two times per day for a period of 6 days 15 min, manual hyperinflation from supine lying in addition to routine chest physiotherapy 21 Active-Treatment of Control Group
Experimental Group manual hyperinflation from side lying two times per day for a period of 6 days. 15 min manual hyperinflation from side lying (upper most affected) in addition to routine chest physiotherapy in the form of percussion, vibration, positioning, and suction were applied. The hyperinflation breath was given as the following: slow inspiration for three seconds duration, three seconds end inspiratory pause (hold) followed by a fast uninterrupted expiration that mimics a forced expiration . The rate of inflation was 10 breaths per minute. The patients had received manual hyperinflation using bag valve resuscitation circuit by the 2-handed technique. Termination of manual hyperinflation occured, if the patient became cardiovascular un stable or if oxygen saturation dropped. 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
mechanically ventilated patients with ventilator associated pneumonia according to chest x-ray male gender ages ranged from 40-50 years the body mass index ranged from 18.5 to 29.9 kg/ m2 hemodynamic stability. contraindications to assume different positions bilateral lung dysfunction unstable cardiovascular conditions e.g arrhythmia history of pulmonary tuberculosis intercostal catheter with a visible air leak. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 Year(s) Male
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 04/04/2017 research ethical committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7th ahamd elzyyat street ben elsarayyt giza 12111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PaO2 pre and post intervention period
Secondary Outcome Partial pressure of carbon dioxide (PaCO2) pre and post intervention
Secondary Outcome Oxygen saturation (SaO2) pe and post intervention period
Secondary Outcome ratio of partial pressure of oxygen and fraction inspired oxygen (PaO2/FiO2). pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Intensive Care Unit faculty of medicine cairo university Kasr El-Aini street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
basant hamdy elrefaey 6th mostagad street elmesaha, el haram giza 12111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University kasr elaini street Cairo 12111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Said Zidan khalupeia khalupeia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator basant Elrefay bassanthamdy@yahoo.com 01001224979 6th Mostaged street, elmesaha, elharam,
City Postal code Country Position/Affiliation
Giza 12111 Egypt assistant professor faculty of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries basant Elrefay bassanthamdy@yahoo.com 01001224979 6th mostaged street, elmesaha, elharam
City Postal code Country Position/Affiliation
Giza 12111 Egypt assistant professor faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries basant Elrefay bassanthamdy@yahoo.com 01001224979 6th mostaged street, elmesaha, elharam
City Postal code Country Position/Affiliation
Giza 12111 Egypt assistant professor faculty of physical therapy cairo university
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
Yes After sessions, significant changes of measured variables ( PaO2 , PaCO2 , PaO2/FiO2 and SaO2) were obtained in both groups (P< 0.05, in all variables) and by comparison between groups post intervention, a significant difference was observed between both groups in measures of oxygenation in favor of group (B) (P< 0.05), whereas there was a non significant difference in the PaC02 between both groups (Post1 P=0.52 and Post2 P=0.33). 30/08/2019 01/01/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks unfortunately no link is present
Changes to trial information