Clinical trial NCT03284892: Screening and Intervention of Postextubation Dysphagia
Official title: Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Swallowing Disorder
Randomized Controlled Trial
Endotracheal Intubation
Keywords: postextubation dysphagia
endotracheal intubation
randomized controlled trial
dysphagia intervention
dysphagia screening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-09-15
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Detailed description: Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Eligibility criteria: Inclusion Criteria:

* Patient who is over 20 years old.
* Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.

Exclusion Criteria:

* Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.
* Patient who has preexisting difficulty swallowing.
* Patient who has received a tracheostomy.
* Patient who were unable to follow verbal instructions.
* Patient who were on contact and droplet precautions (e.g., open tuberculosis)
* Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention

Primary outcomes:
measure: Resumption of oral feeding
timeFrame: Postextubation 7 days
measure: Incidence of penetration and aspiration
timeFrame: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
measure: Incidence of pneumonia
timeFrame: Postextubation 30 days
Secondary outcomes:
measure: Incidence of feeding tube dependency
timeFrame: Postextubation 30 days
measure: Unstimulated salivary flow rate (centimeter/5 minutes)
timeFrame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
measure: Oral health status score
timeFrame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
measure: Lip closure and lingual diadochokinetic status
timeFrame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Cheryl Chia-Hui Chen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siao SF, Tseng WH, Wang TG, Wei YC, Hsiao TY, Ku SC, Chen CC. Predicting feeding-tube dependence in patients following endotracheal extubation: a two-item swallowing screen. BMC Pulm Med. 2021 Dec 6;21(1):403. doi: 10.1186/s12890-021-01771-5.