Critical IllnessCOVID-USNCT04419064
Confirmation of Ventilation and Intubation by Determination With Ultrasonography
An observational study of Critical Illness and Mechanical Ventilation, run by University of Pittsburgh at 4 sites in United States.
Trial summary
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation
- What is being tested?
- Point of care ultrasound
- How many people
- 118 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2019to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, > 18 years of age, undergoing intubation and mechanical ventilation from 4 multiple intensive care units from 4 different academic and community hospitals.
Who may be able to join
- Adult patients (> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care
Who cannot join
- Recent neck or chest surgery
- Cervical spine immobilization
- Lack of availability of operators or equipment for performing the ultrasound protocol
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor St. Luke's Medical Center
Houston, Texas, 77030
University of Pittsburgh
Pittsburgh, Pennsylvania, 15217
Kadlec Regional Medical Center
Richland, Washington, 99352
About this study
Official title: Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.
Read the detailed description
Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.
- Conditions
- Critical Illness, Mechanical Ventilation
- Being tested
- Point of care ultrasound
- Keywords
- intubation, bedside ultrasound, point-of-care ultrasound
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDiagnostic test
Tracheal and lung ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance with next occurring chest radiograph
Adequate endotracheal tube position in agreement with chest radiograph
Measured: within 24 hours
Secondary outcomes (2)
Esophageal Intubation detection
Number of esophageal intubations detected during intubation attempt
Measured: within intubation attempt
Right main or endobronchial intubation
Number of right main stem intubations detected with ultrasonography
Measured: within intubation attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jan 2019
- Primary completion20 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Kadlec Regional Medical Center, The Cleveland Clinic, Baylor College of Medicine, Oregon Health and Science University
- Responsible party
- Principal investigator, Mourad Senussi, University of Pittsburgh
- Investigators
- Mourad H Senussi, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419064
- Sponsor's protocol ID
- STUDY20050011
- Acronym
- COVID-US
- Status last verified
- Oct 2020
- First submitted
- 2 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT04419064
- Acronym / sponsor ID
- COVID-US / STUDY20050011
- Conditions
- Critical Illness, Mechanical Ventilation
- Keywords
- intubation, bedside ultrasound, point-of-care ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Kadlec Regional Medical Center, The Cleveland Clinic, Baylor College of Medicine, Oregon Health and Science University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.
Detailed description
Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, > 18 years of age, undergoing intubation and mechanical ventilation from 4 multiple intensive care units from 4 different academic and community hospitals.
Key inclusion criteria (1 listed)
- Adult patients (> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care
Key exclusion criteria (3 listed)
- Recent neck or chest surgery
- Cervical spine immobilization
- Lack of availability of operators or equipment for performing the ultrasound protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ultrasoundTracheal and lung ultrasonography | Diagnostic test | – |
Primary outcome
Concordance with next occurring chest radiograph
Time frame: within 24 hours
Adequate endotracheal tube position in agreement with chest radiograph
2 secondary outcomes
Esophageal Intubation detection
Time frame: within intubation attempt
Right main or endobronchial intubation
Time frame: within intubation attempt
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mourad H Senussi, MD, MS principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Mechanical Ventilation, run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance with next occurring chest radiograph (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.