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

How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation

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.

Study Overview

• Status: Withdrawn
• Conditions: Patients Requiring Non-invasive Ventilation
• Intervention / Treatment: Other: Oral Intake Screening Tool

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, W2 1NY
    • St Marys Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit

Description

Patients

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre Introduction; Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited)
Nurses; 12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited)
Post Introduction; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mid Arm Circumference Change	Day 1, 3, 7, 14

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Gary Frost, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Nutrition; Malnutrition; Critical Care; Non-Invasive Ventilation; Bi-Level Positive Airway Pressure; Staff attitudes, knowledge and beliefs
• Other Study ID Numbers: 13IC0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No