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.: PACTR202210515878180 Date of Registration: 03/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF POSITIVE EXPIRATORY PRESSURE THERAPY USING ACAPELLA AND LATEX GLOVE DEVICES ON LUNG FUNCTION OF ABDOMINAL SURGERY PATIENTS
Official scientific title EFFECT OF POSITIVE EXPIRATORY PRESSURE THERAPY USING ACAPELLA AND LATEX GLOVE DEVICES ON LUNG FUNCTION OF ABDOMINAL SURGERY PATIENTS
Brief summary describing the background and objectives of the trial There is need to ascertain the effectiveness of the Improvised Latex Glove Device in improving lung function post abdominal surgery. This study compared the effect of Positive Expiratory Pressure Therapy using Latex Glove Device and Acapella Device on lung function parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 11/10/2016
Actual trial start date 11/10/2016
Anticipated date of last follow up 17/01/2017
Actual Last follow-up date 16/01/2017
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
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 Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Improvised Latex Glove Device Ten blows per session thrice daily for ten days Ten days The Participants in the Improvised latex glove PEP device group were given treatment in sitting position. The participants were instructed to take a deep breath hold for 2-3 seconds and then to exhale through the latex glove device actively but not forcefully. There was a 2-minute period of rest after 2-3 repetition of the procedure to avoid patient becoming dyspneic. The procedure was repeated for ten breaths over a 20-minute period, three times a day, for the first 10 postoperative days. 23 Active-Treatment of Control Group
Experimental Group Acapella Device Ten blows per session thrice daily for ten days Ten days Participants in Acapella PEP device (Control group) were taught how to use the Acapella device. The resistance of the device was fixed at the same resistance for every participant that used this device and patients were instructed not to alter it. The Participants were given treatment in sitting position. Participants were instructed to take a deep breath hold for 2-3 seconds and then to exhale through the device actively but not forcefully. There was a two minute periods of rest after 2-3 repetition of the procedure to avoid patient becoming dyspneic. The procedure was repeated for ten breaths over a 20-minute period, three times a day, for the first 10 postoperative days. Participants were instructed to avoid having a full stomach for the breathing sessions. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient who underwent upper abdominal surgery Patients with previous cardiac surgery, left main coronary disease, unstable angina pectoris within the past 48 hours. Patients with pulmonary disease (atelectasis, pleural effusion, pneumonia, or chronic obstructive pulmonary disease). Patients with moderate to severe valvular disease and previous stroke. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 10/10/2016 Health Research Health Committee
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University Osogbo 220005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Forced Vital Capacity Day before surgery, six hours after recovery from anaesthesia, and 4th, 8th and 10th day post-surgery respectively
Secondary Outcome Forced Expiratory Volume in one second and Peak Expiratory Flow Rate Day before surgery, six hours after recovery from anaesthesia, and 4th, 8th and 10th day post-surgery respectively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife Osogbo 220005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chidozie Mbada Obafemi Awolowo University Osobo 220005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chidozie Mbada Obafemi Awolowo University Osogbo 220005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada cembada@oauife.edu.ng +2348028252543 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Chizoba Igwe igwechizobafj@gmail.com +2348037300297 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Chizoba Igwe igwechizobafj@gmail.com +23437300297 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodological sound proposal to achieve aims in the research proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/10/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information