Aspiration in Acute Respiratory Failure Survivors 2

Official title

Aspiration in Acute Respiratory Failure Survivors

Overview

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.

Detailed description

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. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.

Interventions

• Diagnostic test 3-Screenings Protocol
  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).
• Diagnostic 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 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 pr
• Diagnostic test Tracheal Ultrasound
  Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation

Primary outcome measures

• Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies [Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days]

Secondary outcome measures (5)

• Percentage of participants experiencing non-silent aspiration [Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days]
• Percentage of participants experiencing silent aspiration [Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days]
• Percentage of participants experiencing post-extubation clinical laryngeal edema [Time frame: Within 24 hours after extubation]
• Duration of mechanical ventilation [Time frame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average]
• Duration required for liberation from mechanical ventilation [Time frame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average]

Eligibility criteria

Inclusion criteria

• Admission to an ICU.
• Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Exclusion criteria

• 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).
• Pre-existing head and neck cancer or surgery.
• Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
• Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
• Extubated for greater than 96 hours.
• Inability to obtain informed consent from patient or an appropriate surrogate.
• Age < 18 years.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 5 centers

• Stanford Univerity — Stanford
• University of Colorado — Aurora
• Yale University — New Haven
• Tufts Medical Center — Boston
• Boston University — Boston

Publications

• Kempker JA, Abril MK, Chen Y, Kramer MR, Waller LA, Martin GS. The Epidemiology of Respiratory Failure in the United States 2002-2017: A Serial Cross-Sectional Study. Crit Care Explor. 2020 Jun 10;2(6):e0128. doi: 10.1097/CCE.0000000000000128. eCollection 2020 Jun. PMID 32695994
• Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010 Oct;38(10):1947-53. doi: 10.1097/CCM.0b013e3181ef4460. PMID 20639743
• Barker J, Martino R, Reichardt B, Hickey EJ, Ralph-Edwards A. Incidence and impact of dysphagia in patients receiving prolonged endotracheal intubation after cardiac surgery. Can J Surg. 2009 Apr;52(2):119-24. PMID 19399206
• El Solh A, Okada M, Bhat A, Pietrantoni C. Swallowing disorders post orotracheal intubation in the elderly. Intensive Care Med. 2003 Sep;29(9):1451-5. doi: 10.1007/s00134-003-1870-4. Epub 2003 Aug 2. PMID 12904855
• Macht M, White SD, Moss M. Swallowing dysfunction after critical illness. Chest. 2014 Dec;146(6):1681-1689. doi: 10.1378/chest.14-1133. PMID 25451355
• Macht M, Wimbish T, Bodine C, Moss M. ICU-acquired swallowing disorders. Crit Care Med. 2013 Oct;41(10):2396-405. doi: 10.1097/CCM.0b013e31829caf33. PMID 23939361
• Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823. PMID 20202948
• Moss M, White SD, Warner H, Dvorkin D, Fink D, Gomez-Taborda S, Higgins C, Krisciunas GP, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Vojnik R, Langmore SE. Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors. Chest. 2020 Nov;158(5):1923-1933. doi: 10.1016/j.chest.2020.07.051. Epub 2020 PMID 32721404

Identifiers

NCT: NCT05108896 · 21-3873 · R01NR019989

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗