An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation
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|ClinicalTrials.gov Identifier: NCT02090868|
Recruitment Status : Withdrawn (No patients recruited due to decreased levels of patients requiring non-invasive ventilation during the study.)
First Posted : March 18, 2014
Last Update Posted : August 27, 2020
This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.
This study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.
The study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.
Nurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.
Patients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.
Nurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.
|Condition or disease||Intervention/treatment|
|Patients Requiring Non-invasive Ventilation||Other: Oral Intake Screening Tool|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited)
12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited)
Pre tool introduction cohort 22 patient participants who's ability to eat and drink orally will be assessed using the Oral Intake Screening Tool (no patient participants were recruited)
Other: Oral Intake Screening Tool
A screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so
- Mid Arm Circumference Change [ Time Frame: Day 1, 3, 7, 14 ]
- Fluid Intake Change [ Time Frame: Daily over 14 days ]fluid intake from all sources eg intravenous, nasogastric, oral
- fluid balance change [ Time Frame: daily for 14 days ]fluid intake minus fluid output
- New formation of or worsening of existing pressure sores [ Time Frame: daily for 14 days ]
- new diagnosis of aspiration pneumonia [ Time Frame: daily for 14 days ]
- number of days requiring non-invasive ventilation [ Time Frame: 14 days ]
- number of days requiring level 2 care [ Time Frame: 14 days ]
- length of hospital stay [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090868
|St Marys Hospital|
|London, United Kingdom, W2 1NY|
|Imperial College Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Gary Frost||Imperial College London|