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

Patients Requiring Non-invasive Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02090868
• Other study ID #: 13IC0065
• Status: Withdrawn
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Requiring Non-invasive Ventilation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	St Marys Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mid Arm Circumference Change		Day 1, 3, 7, 14
Secondary	Fluid Intake Change	fluid intake from all sources eg intravenous, nasogastric, oral	Daily over 14 days
Secondary	fluid balance change	fluid intake minus fluid output	daily for 14 days
Secondary	New formation of or worsening of existing pressure sores		daily for 14 days
Secondary	new diagnosis of aspiration pneumonia		daily for 14 days
Secondary	number of days requiring non-invasive ventilation		14 days
Secondary	number of days requiring level 2 care		14 days
Secondary	length of hospital stay		14 days