An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation

Withdrawn

• Conditions: Patients Requiring Non-invasive Ventilation
• Interventions: Other: Oral Intake Screening Tool

• Registration Number: NCT02090868
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• over 18 years old
• require non-invasive ventilation as defined by the protocol

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Exclusion Criteria

• Patients on the Liverpool Care Pathway
• Patients requiring nocturnal non-invasive ventilation only
• Patients with a tracheostomy
• Patients with a nasogastric feeding tube insitu on admission
• Patients with a PEG/RIG tube insitu on admission

Staff

Inclusion Criteria:

• full time employees
• work in the medical high dependency unit

Exclusion Criteria:

• staff only working bank or agency shifts on the medical high dependency unit
• staff who have not had formal high dependency/critical care training
• staff who do not work more than 5 shifts per month in the medical high dependency unit
• staff who have not held a full time post on Douglas Acute Admissions Unit for more than six months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post Introduction	Oral Intake Screening Tool	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)

Primary Outcome Measures

Name	Time	Method
Mid Arm Circumference Change	Day 1, 3, 7, 14

Secondary Outcome Measures

Name	Time	Method
fluid balance change	daily for 14 days	fluid intake minus fluid output
new diagnosis of aspiration pneumonia	daily for 14 days
length of hospital stay	14 days
New formation of or worsening of existing pressure sores	daily for 14 days
number of days requiring level 2 care	14 days
Fluid Intake Change	Daily over 14 days	fluid intake from all sources eg intravenous, nasogastric, oral
number of days requiring non-invasive ventilation	14 days

Trial Locations

Locations (2)

St Marys Hospital; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom