About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admission to an ICU.

Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Disqualifiers

Likely persistent contraindications to enteral/oral nutrition administration.

Pre-existing history of dysphagia or aspiration.

Pre-existing or acute primary central or peripheral neuromuscular disorder.

Presence of a chronic tracheostomy (present prior to ICU admission).

Trial design

Design model

Single group

Treatments tested in this trial

3-Screenings Protocol
Diagnostic test
The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).
FEES
Diagnostic test
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.
Tracheal Ultrasound
Diagnostic test
Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation

Treatment groups

855 Participants

are divided into 1 treatment group

Group A: Aspiration in Acute Respiratory Failure SurvivorsOther 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies

Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies.

Time frame

from extubation day 1 through hospital discharge, expected to be within 28 days

Secondary outcomes

1

Percentage of participants experiencing non-silent aspiration

We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.

Time frame

from extubation day 1 through hospital discharge, expected to be within 28 days

2

Percentage of participants experiencing silent aspiration

We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.

Time frame

from extubation day 1 through hospital discharge, expected to be within 28 days

3

Percentage of participants experiencing post-extubation clinical laryngeal edema

We will define laryngeal edema as upper-airway obstruction within 24 hours after extubation. Minor laryngeal edema will be defined as stridor associated with a respiratory distress defined as a prolonged inspiratory phase and the presence of edema on FEES examination. Major laryngeal edema will defined as severe respiratory distress needing tracheal reintubation secondary to upper-airway obstruction that was visualized during the FEES examination

Time frame

Within 24 hours after extubation

4

Duration of mechanical ventilation

We will also collect the overall length of mechanical ventilation in days

Time frame

from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average

Aspiration in Acute Respiratory Failure Survivors 2

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts