Swallowing Difficulties in ICU Patients [Synkebesvær Hos Intensivpatienter]

NCT04428749 | Unknown

• 1 other identifier: 69184
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Swallow disorders or dysphagia related to mechanical ventilation affects between 1,300 and 2,000 patients in Danish intensive care units every year and increases aspiration, pneumonia and risk of dying. In intensive care units, dysphagia may vary around the clock as fatigue and fluctuating alertness play an important role for the patients' ability to swallow effectively without aspiration to the airway. For this reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night, but guidelines are lacking. One of the simplest and most sensitive methods is the Yale Swallow Protocol, however, this protocol requires translation and validation before it can be implemented in Danish intensive care units. This project aims to translate and validate the Yale Swallow Protocol for use in Danish intensive care units. Furthermore, this project will explore nurses' perceptions and management of dysphagia in the intensive care unit as well as feasibility and acceptability of the Yale Swallow Protocol.

Conditions

Deglutition Disorders; Critical Illness

Outcome Measures

Primary Outcomes (2)

• Aspiration on FEES

  Penetration aspiration scale (PAS scale) equal to or larger than 6

  Within 24 hours of extubation

• Yale Swallow protocol

  Passed or not passed

  Within 30 minutes of the FEES

Secondary Outcomes (1)

• Mortality

  30 days after extubation

Study Arms (1)

Study group

1. Participants are screened using the Yale Swallow Protocol (YSP) 2-4 hours after extubation: Ability to swallow is assessed by an ICU nurse using the YSP. If the YSP is negative, the patient may start oral feeding and drinking. In case of a positive YSP, the screening may be repeated within the next 24 hours provided the patient improves clinically. If YSP continues to be positive the patient is referred to assessment by a speech language pathologist (SLP). 2. Participants are screened within 24 hours: To evaluate YSP against the FEES, the patient undergoes 1) YSP performed by an ICU nurse followed by 2) FEES performed by a SLP (until PAS\>6 (aspiration on any food consistency on the Penetration Aspiration Scale (20)). The SLP will be blinded to the assessment made by the ICU nurses. Patients will follow recommendations for oral feeding and drinking as given by the SLP.

Diagnostic Test: Yale Swallow Protocol; Diagnostic Test: FEES (fiberoptic endoscopic evaluation of swallowing)

Interventions

Yale Swallow Protocol DIAGNOSTIC_TEST

The YSP is a three-step method consisting of an assessment of the patient's awareness, the patient's ability to follow simple instructions and finally the patient's ability to drink 90 ml water from a cup or by straw without stopping, choking or coughing.

Study group

FEES (fiberoptic endoscopic evaluation of swallowing) DIAGNOSTIC_TEST

The FEES will be performed bedside by an experienced occupational therapists. The patient will be sitting upright in a chair and be given 1) 2 spoons of applesauce, 2) 2 spoons of water, 3) several sips of water, 4) 90 ml of water. All items colored blue. The FEES will use a single-use AMBU rhino-laryngo scope slim and the AMBU monitor. the examination will be terminated in case of aspiration below the vocal cords.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients from all clinical specialties who have been extubated after mechanical ventilation.

You may qualify if:

• \> 18 years
• No prior records of dysphagia
• Extubated after mechanical ventilation \> 24 hours.
• Awake and alert with no sign of ICU delirium.
• Must understand Danish, as all information available about the study is in Danish.

You may not qualify if:

• Patients who are unable to undergo the YSP
• Patients who are unable to undergo the FEES

Sponsors & Collaborators

• Hospitalsenheden Vest: lead
• VIA University College: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Regionshospitalet Holstebro

Holstebro, Central Jutland, 7500, Denmark

Location

MeSH Terms

Conditions

Deglutition Disorders; Critical Illness

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne H Nielsen, Ph.d.

  Regional Hospital Holstebro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MCN, PH.D.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: April 1, 2020
• Primary Completion: December 12, 2022
• Study Completion: June 1, 2023
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

DK (1)