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.: PACTR201910465105124 Date of Approval: 24/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of an educational intervention on nurses’ knowledge of managing endotracheal tube cuff pressure in intensive care units: A quasi-experimental study
Official scientific title Management of Endotracheal Tube Cuff Pressure in Mechanically Ventilated Adult Patients in Intensive Care Units in Malawi
Brief summary describing the background and objectives of the trial Previous studies conducted on nurses’ knowledge regarding endotracheal tube cuff pressure revealed that there were differences in intensive care nurses’ knowledge, leading to varying practices. This study aimed to evaluate the effect of an educational intervention based on existing evidence-based guidelines, on the knowledge of nurses regarding managing endotracheal tube cuff pressures in Malawian intensive care units.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied endotracheal tube cuff pressure
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2016
Actual trial start date 01/02/2016
Anticipated date of last follow up 01/07/2016
Actual Last follow-up date 01/07/2016
Anticipated target sample size (number of participants) 61
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL na
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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group educational intervention intervention group 2 na 3 months Full intervention: the half-day educational session using a PowerPoint presentation, a printed version of the evidence-based guidelines, and a summary of the evidence-based guidelines and the algorithm and four monitoring visits 27
Control Group Educational intervention group 1 na 3 months partial educational intervention, including half-day educational session using PowerPoint presentation, a printed version of the evidence-based guidelines, and a summary of the evidence-based guidelines and the algorithm 25 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the nurses working in the selected ICUs for the duration of the study na Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 17/11/2014 Faculty Postgraduate Studies Committee Nelson Mandela Metropolitan University
Ethics Committee Address
Street address City Postal code Country
University Way Port Elizabeth 6031 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improving nurses’ knowledge of managing endotracheal tube cuff pressure in intensive care units post-intervention with post-test
Secondary Outcome The impact of the improved knowledge on patient outcomes in terms of complications related to endotracheal cuff pressure n/a
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Blantyre Adventist Hospital PO Box 51 Blantyre 0051 Malawi
Kamuzu Central Hospital PO 149 Lilongwe 0149 Malawi
Queen Elizabeth Central Hospital PO Box 95 Blantyre 0095 Malawi
Mzuzu Central Hospital PO Box 209 Luwinga 0209 Malawi
Mwaiwathu Private Hospital PO Box 3067 Blantyre 3067 Malawi
Zomba Central Hospital PO Box 21 Zomba 0021 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
prof Dalena van Rooyen PI university Way Port Elizabeth 6031 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Prof D van Rooyen Supervisor University Way Port Elizabeth 6031 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Ms Ferestas Mpasa PO box 122 Zomba City 0109 Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalena van Rooyen dalena.vanrooyen@mandela.ac.za +2790745905 University Way
City Postal code Country Position/Affiliation
Port Elizabeth 6031 South Africa Deputy Dean
Role Name Email Phone Street address
Public Enquiries Marilyn Afrikaner marilyn.afrikaner@mandela.ac.za +27415042956 University Way
City Postal code Country Position/Affiliation
Port Elizabeth 6031 South Africa Faculty of Health Sciences contact person
Role Name Email Phone Street address
Scientific Enquiries Wilma ten HamBaloyi wilma.tenham-baloyi@mandela.ac.za +2790745905 University Way
City Postal code Country Position/Affiliation
Port Elizabeth 6031 South Africa Faculty of Health Sciences Research Associate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes in principle all data from the study will be available on request Clinical Study Report 12 months after study completion Researchers interested in the study's results may request controlled access In principle all data analysed may be requested by sending an email to the PI The PI in consultation with the University will decide whether and what data can be accessed Criteria for reviewing requests include the quality of the request (relevance as to why the data is requested will be considered in granting access) and the credibility (qualifications, affiliation) of the person requesting the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available as study has not been published yet Yes Results of the study include: Knowledge on the nursing care practices for the management of endotracheal tube cuff pressure was improved for both groups following the educational intervention, although only the results comparing the Intervention 2 group participants’ indicate that the level of knowledge were significant (t(d.f.=48)=2.08, p=0.043, d=0.59). 22/10/2019 01/05/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks protocol not available
Changes to trial information