NCT03761823

Brief Summary

Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia. Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 11, 2024

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 2, 2018

Last Update Submit

April 10, 2024

Conditions

Post-extubation Dysphagia

Keywords

Flexible endoscopic evaluation of swallowingHigh resolution impedance manometryElectromyographyIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • The number of patients with aspiration during FEES will be assessed.

    At time of measurement (within 24 hours post-extubation)

Secondary Outcomes (4)

  • Pathophysiology of PED

    At time of measurement (within 24 hours post-extubation)

  • The number of adverse events will be assessed.

    Participants will be followed until hospital discharge, an expected average of 28 days

  • Interaction of FEES on HRIM recording

    At time of measurement (within 24 hours post-extubation)

  • Correlation of FEES with HRIM

    At time of measurement (within 24 hours post-extubation)

Other Outcomes (7)

  • The number of patients that develop pneumonia will be assessed.

    Participants will be followed until hospital discharge, an expected average of 28 days

  • Reintubation rate (dysphagia vs. non-dysphagia)

    Participants will be followed until hospital discharge, an expected average of 28 days

  • ICU readmission rate (dysphagia vs. non-dysphagia)

    Participants will be followed until hospital discharge, an expected average of 28 days

  • +4 more other outcomes

Study Arms (2)

Healthy subjects

Healthy subjects

Patients

Patients extubated after \> 5 days of mechanical ventilation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects will be recruited using posters at the local university and the internet. Intensive care patients that will be extubated shortly.

You may qualify if:

  • age \> 18 years
  • informed consent
  • extubated after endotracheal intubation for more than 5 days
  • Richmond Agitation-Sedation Scale (RASS) between -2 and 2
  • able to sit right up
  • no respiratory insufficiency/failure (for this study defined as oxygen saturation (SpO2) \< 92% with a minimum of 3 L nasal oxygen)
  • age \> 18 years
  • informed consent

You may not qualify if:

  • pre-existing dysphagia (according to medical record and screening)
  • tracheostomy or previous tracheostomy
  • history of prior intubation \< 3 months ago
  • head/neck surgery, head/neck radiation or head/neck disease
  • pre-existent esophageal disorder
  • coagulopathy (thrombocytes \< 50\*10\^9 /l, or prothrombin time (PT)/activated partial thromboplastin time (APTT) \> 1.5 times the reference value, or fibrinogen \< 1000 mg/l, or use of therapeutic anticoagulant drugs)
  • allergy for xylometazoline (only in case its use is indicated)
  • known pregnancy
  • known G6PD deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Study Officials

  • Johannes G. van der Hoeven, prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

December 3, 2018

Study Start

January 22, 2019

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 11, 2024

Record last verified: 2022-03

Locations

NL(1)