Clinical trial NCT02090868: An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation
Official title: How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patients Requiring Non-invasive Ventilation
Keywords: Non-Invasive Ventilation
Bi-Level Positive Airway Pressure
Continuous Positive Airway Pressure
Critical Care
Nutrition
Malnutrition
Staff attitudes, knowledge and beliefs
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mid Arm Circumference Change
timeFrame: Day 1, 3, 7, 14
Secondary outcomes:
measure: Fluid Intake Change
timeFrame: Daily over 14 days
measure: fluid balance change
timeFrame: daily for 14 days
measure: New formation of or worsening of existing pressure sores
timeFrame: daily for 14 days
measure: new diagnosis of aspiration pneumonia
timeFrame: daily for 14 days
measure: number of days requiring non-invasive ventilation
timeFrame: 14 days
measure: number of days requiring level 2 care
timeFrame: 14 days
measure: length of hospital stay
timeFrame: 14 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Marys Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Gary Frost
role: PRINCIPAL_INVESTIGATOR
References: