Trial Outcomes & Findings for Aspiration in Acute Respiratory Failure Survivors (NCT NCT02363686)
NCT ID: NCT02363686
Last Updated: 2021-07-12
Results Overview
Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
from extubation Day 1 through hospital discharge, expected to be within 28 days
Results posted on
2021-07-12
Participant Flow
Overall, 213 patients were included in the final analysis
Participant milestones
| Measure |
FEES & Bedside Swallow Evaluation (BSE)
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
|
|---|---|
|
Overall Study
STARTED
|
248
|
|
Overall Study
COMPLETED
|
213
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
FEES & Bedside Swallow Evaluation (BSE)
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
incomplete FEES examinations
|
13
|
Baseline Characteristics
Aspiration in Acute Respiratory Failure Survivors
Baseline characteristics by cohort
| Measure |
FEES & Bedside Swallow Evaluation (BSE)
n=213 Participants
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
212 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: from extubation Day 1 through hospital discharge, expected to be within 28 daysPopulation: Overall, 213 patients were included in the final analysis.
Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food.
Outcome measures
| Measure |
FEES & Bedside Swallow Evaluation (BSE)
n=213 Participants
A speech language pathologist (SLP) will perform a bedside swallowing evaluation (BSE).followed by a Fiberoptic Endoscopic Evaluation of Swallowing (FEES). BSE: Before the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with five food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
.
|
|---|---|
|
Percentage of Participants Experiencing Aspiration
Overall aspiration
|
70 percentage of participants
|
|
Percentage of Participants Experiencing Aspiration
Non-silent aspiration
|
52 percentage of participants
|
Adverse Events
FEES & Bedside Swallow Evaluation (BSE)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FEES & Bedside Swallow Evaluation (BSE)
n=248 participants at risk
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
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|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.81%
2/248 • Number of events 2 • Through study completion, about 28 days
|
|
Gastrointestinal disorders
GI bleed
|
0.40%
1/248 • Number of events 1 • Through study completion, about 28 days
|
|
Gastrointestinal disorders
penetration
|
0.40%
1/248 • Number of events 1 • Through study completion, about 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place