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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC group | Experimental | Received SOC program addition to usual care |
|
| Control group | No Intervention | Received usual care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC program | Behavioral | A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resumption of oral feeding | Measured by Functional Oral Intake Scale | Postextubation 7 days |
| Incidence of penetration and aspiration | Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure. | Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation |
| Incidence of pneumonia | Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria. | Postextubation 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of feeding tube dependency | Abstracted from electronic medical records | Postextubation 30 days |
| Unstimulated salivary flow rate (centimeter/5 minutes) | Measured by the whatman 41 test strip |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Chia-Hui Chen, Prof. | School of Nursing, College of Medicine, National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10055 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37438759 | Derived | Siao SF, Ku SC, Tseng WH, Wei YC, Chang YC, Hsiao TY, Wang TG, Chen CC. Effects of a swallowing and oral-care program on resuming oral feeding and reducing pneumonia in patients following endotracheal extubation: a randomized, open-label, controlled trial. Crit Care. 2023 Jul 12;27(1):283. doi: 10.1186/s13054-023-04568-6. | |
| 34872549 |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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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.
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To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.
| Time points of assessments: within 48 hours postextubation and at the day 10 postextubation |
| Oral health status score | Measured by the oral Assessment Guide | Time points of assessments: within 48 hours postextubation and at the day 10 postextubation |
| Lip closure and lingual diadochokinetic status | Measured by the Frenchay Dysarthria Assessment | Time points of assessments: within 48 hours postextubation and at the day 10 postextubation |
| 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. |
| D010038 | Otorhinolaryngologic Diseases |