Swallowing Assessment Protocols for Aspiration in Respiratory Failure Survivors
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Dysphagia, Neuromuscular disorder, Tracheostomy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment 3-Screenings Protocol, FEES, Tracheal Ultrasound for aspiration in respiratory failure survivors?
Research shows that using ultrasound to observe swallowing can help improve safe eating and drinking in people with swallowing problems, reducing the risk of choking and pneumonia. This suggests that tracheal ultrasound, as part of the treatment, may be effective in assessing and managing swallowing issues in respiratory failure survivors.
12345Is the Swallowing Assessment Protocol safe for humans?
Research shows that using ultrasound for swallowing assessments is generally safe, as no cases of pneumonia or suffocation were reported during studies. This suggests that the protocol is safe for humans.
12456How does the swallowing assessment protocol treatment differ from other treatments for aspiration in respiratory failure survivors?
The swallowing assessment protocol is unique because it focuses on bedside evaluations to detect aspiration risk in respiratory failure survivors, aiming to reduce complications and allow for timely oral nutrition. This approach is less invasive compared to other methods like fiberoptic endoscopic evaluation of swallowing (FEES), which requires specialized equipment and expertise.
24789Eligibility Criteria
This trial is for adults who've been in the ICU and on a ventilator for over 48 hours. It's not suitable for those with uncontrolled bleeding, persistent delirium after extubation, neuromuscular disorders, chronic tracheostomy before ICU admission, head and neck cancer or surgery history, under 18s, prior swallowing issues or aspiration history.Inclusion Criteria
I have been on a breathing machine with a tube for more than 2 days.
I have been admitted to an intensive care unit.
Exclusion Criteria
I have a muscle or nerve disorder affecting my brain, spinal cord, or nerves.
Inability to obtain informed consent from patient or an appropriate surrogate
You have been breathing without a tube for more than 72 hours.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-Extubation Assessment
Participants receive a tracheal ultrasound within 72 hours prior to extubation and collection of demographic and hospital clinical information
Up to 3 days
Post-Extubation Assessment
Administration of 3 screening tests addressing swallowing function within 24 hours post-extubation and a fiberoptic endoscopic examination of swallowing (FEES) exam
1 day
Follow-up
Participants are monitored for post-extubation dysphagia and aspiration from extubation day 1 through hospital discharge
Up to 28 days
Participant Groups
The study tests three methods to understand swallowing problems post-acute respiratory failure: FEES (a type of swallow test), a protocol involving three screenings for swallowing safety, and tracheal ultrasound to assess airway management.
1Treatment groups
Experimental Treatment
Group I: Aspiration in Acute Respiratory Failure SurvivorsExperimental Treatment3 Interventions
All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniverityStanford, CA
Tufts Medical CenterBoston, MA
Yale UniversityNew Haven, CT
University of ColoradoAurora, CO
More Trial Locations
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Diagnostic accuracy of ultrasound examination in detecting aspiration and pharyngeal residue in patients with dysphagia: A systematic review and meta-analysis. [2021]To estimate diagnostic accuracy of ultrasonography for detecting aspiration and pharyngeal residue in patients with dysphagia.
Can bedside assessment reliably exclude aspiration following acute stroke? [2019]To investigate the ability of a bedside swallowing assessment to reliably exclude aspiration following acute stroke.
Assessing Swallowing Dysfunction Aggravation in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonic Measurements With Swallowing Movement Parameters. [2023]To investigate the correlation between ultrasonic measurements of swallowing movement parameters and aggravation of swallowing dysfunction in patients with chronic obstructive pulmonary disease (COPD).
Swallowing and Aspiration Risk: A Critical Review of Non Instrumental Bedside Screening Tests. [2023]The presence of dysphagia and aspiration in stroke patients is associated with increased mortality and morbidity. Early recognition and management of these two conditions via reliable, minimally invasive bedside procedures before complications arise remains challenging in everyday clinical practice. This study reviews the available bedside screening tools for detecting swallowing status and aspiration risk in acute stroke by qualitatively observing reference population study design, clinical flexibility, reliability and applicability to acute-care settings.
Effectiveness of Swallowing Care on Safe Oral Intake Using Ultrasound-Based Observation of Residues in the Epiglottis Valley: A Pragmatic, Quasi-Experimental Study. [2020]The demand for methods to ensure safe oral consumption of food and liquids in order to prevent aspiration pneumonia has increased over the last decade. This study investigated the safety of swallowing care selected by adding ultrasound-based observation, evaluated its efficacy, and determined effective content of selected swallowing care. The study employed a pragmatic quasi-experimental research design. Participants were 12 community-dwelling adult patients (age: 44-91 years) who had experienced choking within 1 month prior to the study. After the control phase, in which conventional swallowing care was provided, trained nurses provided ultrasound observation-based swallowing care for a minimum period of 2 weeks. Outcome measurements were compared across three points, namely T1-beginning of the control phase, T2 and T3-before and end of the intervention phase. The mean durations of intervention were 30.8 days in the control phase and 36.5 days in the intervention phase. Pneumonia and suffocation did not occur in the control phase or the intervention phase. The safe intake food level and the food intake level score significantly improved during the intervention phase (p = 0.032 and 0.017, respectively) by adding eating training based on the ultrasound observation. However, there was no significant improvement in the strength of the muscle related to swallowing by the selected basic training. Our results suggest that swallowing care selected based on the ultrasound observation, especially eating training, safely improved safe oral intake among community-dwelling adults with swallowing dysfunction.
A Randomized Controlled Trial to Investigate the Effectiveness of the Prevention of Aspiration Pneumonia Using Recommendations for Swallowing Care Guided by Ultrasound Examination. [2020]Prevention for aspiration pneumonia requires assessment of aspiration and adequate swallowing care. This randomized controlled trial aimed to investigate the effectiveness of ultrasound examination and recommendations for swallowing care for the reduction of aspiration and pharyngeal post-swallow residue as compared with standard swallowing care. Twenty-three participants were randomized to the intervention group and 23 to the control group. The intervention consisted of four ultrasound examinations during mealtimes and recommendations for swallowing care every 2 weeks during an 8 week period. No recommendations concerning swallowing care based on ultrasound examinations were provided to the control group. The frequency of aspiration or residue was defined as x/y × 100% when aspiration or residue were detected x times from y times concerning the total ultrasound measurements. The proportion of the residents with reduced frequency of aspiration which was detected by ultrasonography at eight weeks were 4.3% in the intervention group and 0% in the control group. The median reduction in the frequency of aspiration and residue in the intervention group was 31%, and that in the control group was 11%. In conclusion, swallowing care guided by frequent ultrasound examinations during mealtimes had a trend of reducing the frequency of aspiration and residue during an 8-week period in individuals relative to standard swallowing care alone.
Early assessment of aspiration risk in acute stroke by fiberoptic endoscopy in critically ill patients. [2022]Fiberoptic endoscopic evaluation of swallowing (FEES) has been recommended to assess aspiration in stroke. This study aimed to determine the diagnostic and prognostic roles of FEES in the early assessment of aspiration, intensive care unit (ICU) stay and mortality in acute stroke patients.
The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. [2018]Dysphagia with subsequent aspiration occurs in up to 60% of acute respiratory failure (ARF) survivors. Accurate bedside tests for aspiration can reduce aspiration-related complications while minimizing delay of oral nutrition. In a cohort of ARF survivors, we determined the accuracy of the bedside swallowing evaluation (BSE) and its components for detecting aspiration.
FEES protocol derived estimates of sensitivity: aspiration in dysphagic patients. [2021]Aspiration is a common phenomenon in patients with oropharyngeal dysphagia. It can be studied using fiberoptic endoscopic evaluation of swallowing (FEES). FEES is well known and widely used in the diagnosis and treatment of swallowing disorders. However, various protocols exist, and there is no consensus on the examination protocol. The objective of this prospective study was to determine the FEES protocol derived estimates of sensitivity (Se') to detection of aspiration in dysphagic patients. The study estimated the probability of aspiration as a function of the number of swallow trials in dysphagic patients using FEES. The derived sensitivity was calculated based on presence or absence of aspiration in a ten-swallow trial protocol as arbitrary 'gold standard'. Eighty-four persons were included, comprising two patient populations with oropharyngeal dysphagia. Dysphagia in one group was due to head and neck cancer and possible oncological treatment effects on swallowing; in the other it was a result of neurological disease. All patients underwent a standardized FEES examination using ten swallows of thin liquid followed by ten swallows of thick liquid, all in boluses of 10 cc each. FEES recordings were rated for aspiration by an expert panel blinded to patients' identity and clinical history. Descriptive statistics, Kaplan-Meier survival analysis techniques, and Log Rank/Mantel-Cox tests were used. In both patient populations the aspiration risk was underestimated when using a limited number (three or four) of swallow trials. The oncology and neurology patients differed significantly in the number of swallow trials required to determine aspiration for thin liquids (median values 2 and 7 respectively, P = 0.006). FEES protocols using a limited number of swallow trials can underestimate the aspiration risk in both oncological and neurological patients suffering from oropharyngeal dysphagia, especially when using boluses with a thin liquid consistency.