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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Recruitment Status : Withdrawn (No patients recruited due to decreased levels of patients requiring non-invasive ventilation during the study.)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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Patients Requiring Non-invasive Ventilation 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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




Primary Outcome Measures :
  1. Mid Arm Circumference Change [ Time Frame: Day 1, 3, 7, 14 ]

Secondary Outcome Measures :
  1. Fluid Intake Change [ Time Frame: Daily over 14 days ]
    fluid intake from all sources eg intravenous, nasogastric, oral

  2. fluid balance change [ Time Frame: daily for 14 days ]
    fluid intake minus fluid output

  3. New formation of or worsening of existing pressure sores [ Time Frame: daily for 14 days ]
  4. new diagnosis of aspiration pneumonia [ Time Frame: daily for 14 days ]
  5. number of days requiring non-invasive ventilation [ Time Frame: 14 days ]
  6. number of days requiring level 2 care [ Time Frame: 14 days ]
  7. length of hospital stay [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit
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

Information from the National Library of Medicine

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


Locations
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United Kingdom
St Marys Hospital
London, United Kingdom, W2 1NY
Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Gary Frost Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02090868    
Other Study ID Numbers: 13IC0065
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Non-Invasive Ventilation
Bi-Level Positive Airway Pressure
Continuous Positive Airway Pressure
Critical Care
Nutrition
Malnutrition
Staff attitudes, knowledge and beliefs