Respiratory FailurePhase 4Check-UPNCT02497729
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
A Phase 4 study testing Written Checklist and Head of Bed Up in people with Respiratory Failure, run by Vanderbilt University at 5 sites in United States.
Trial summary
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Written Checklist and Head of Bed Up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2015to Sep 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Who cannot join
- Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Vanderbilt University
Nashville, Tennessee, 37232
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112
Ochsner Medical Center
New Orleans, Louisiana, 70115
University of Washington
Seattle, Washington, 98104
About this study
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Read the detailed description
Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
- Conditions
- Respiratory Failure
- Being tested
- Written Checklist, Head of Bed Up
- Keywords
- Endotracheal Intubation, Checklist, Positioning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written ChecklistProcedure or surgery
Also called Checklist
Use of a written checklist pre and peri-intubation
Head of Bed UpProcedure or surgery
Also called Patient Positioning, Sniff Position
Raising the patient's head of bed to 25 degrees
| Study group | Role | What they receive |
|---|---|---|
| Sniffing Position, No Checklist | No intervention | Patient in the sniffing position without the use of a written checklist |
| Sniffing Position, Checklist | Active comparator | Patient in the sniffing position with the use of a written checklist Receives: Procedure: Written Checklist |
| Head of Bed Up, No Checklist | Active comparator | Patient with the head of bed up and without the use of a checklist Receives: Procedure: Head of Bed Up |
| Head of Bed Up, Checklist | Active comparator | Patient with the head of bed up and with the use of a checklist Receives: Procedure: Written Checklist; Procedure: Head of Bed Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
Measured: Time of Induction through 2 minutes after successful intubation
Lowest Systolic Blood Pressure (Checklist intervention only)
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
Measured: Time of Induction through 2 minutes after successful intubation
Secondary outcomes (14)
Incidence of Desaturation
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Measured: Time of Induction through 2 minutes after successful intubation
Incidence of Hypoxemia
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Measured: Time of Induction through 2 minutes after successful intubation
Change in Saturation
Change in oxygen saturation from baseline to lowest oxygen saturation
Measured: Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View
Cormack-Lehane grade of view on first intubation attempt
Measured: Time of Induction through 2 minutes after successful intubation
First Pass Success
Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
Measured: Time of Induction through 2 minutes after successful intubation
Number of Intubation Attempts
Number of attempts required for successful tube placement
Measured: Time of Induction through 2 minutes after successful intubation
Time to Intubation
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Measured: Time of Induction through 2 minutes after successful intubation
Need for Assistance
Incidence of need for additional intubating equipment, second operator
Measured: Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications
Incidence of non-oxygenation complications - composite of all other recorded complications
Measured: Time of Induction through 2 minutes after successful intubation
Malposition of Endotracheal Tube
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Measured: Time of Induction through 2 minutes after successful intubation
Repositioning Patient
Incidence of repositioning patient after procedure initiation
Measured: Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality
Death before hospital discharge
Measured: From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days
Days alive and free from mechanical ventilation
Measured: From enrollment through study day 28
ICU-Free Days
Days alive and out of the ICU
Measured: From enrollment through study day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University
- Investigators
- Todd W Rice, MD, MSc, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497729
- Sponsor's protocol ID
- 150897
- Acronym
- Check-UP
- Status last verified
- Sep 2016
- First submitted
- 6 Jul 2015
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
PubMed 28917549Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
PubMed 28487139
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
- ClinicalTrials.gov ID
- NCT02497729
- Acronym / sponsor ID
- Check-UP / 150897
- Conditions
- Respiratory Failure
- Keywords
- Endotracheal Intubation, Checklist, Positioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Detailed description
Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sniffing Position, No Checklist | No intervention | –Patient in the sniffing position without the use of a written checklist |
| Sniffing Position, Checklist | Active comparator | Procedure: Written ChecklistPatient in the sniffing position with the use of a written checklist |
| Head of Bed Up, No Checklist | Active comparator | Procedure: Head of Bed UpPatient with the head of bed up and without the use of a checklist |
| Head of Bed Up, Checklist | Active comparator | Procedure: Written Checklist, Procedure: Head of Bed UpPatient with the head of bed up and with the use of a checklist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Key exclusion criteria (4 listed)
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
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 |
|---|---|---|
| Written ChecklistAlso: ChecklistUse of a written checklist pre and peri-intubation | Procedure or surgery | Head of Bed Up, Checklist, Sniffing Position, Checklist |
| Head of Bed UpAlso: Patient Positioning, Sniff PositionRaising the patient's head of bed to 25 degrees | Procedure or surgery | Head of Bed Up, Checklist, Head of Bed Up, No Checklist |
Primary outcome
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Time frame: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
Lowest Systolic Blood Pressure (Checklist intervention only)
Time frame: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
14 secondary outcomes
Incidence of Desaturation
Time frame: Time of Induction through 2 minutes after successful intubation
Incidence of Hypoxemia
Time frame: Time of Induction through 2 minutes after successful intubation
Change in Saturation
Time frame: Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View
Time frame: Time of Induction through 2 minutes after successful intubation
First Pass Success
Time frame: Time of Induction through 2 minutes after successful intubation
Number of Intubation Attempts
Time frame: Time of Induction through 2 minutes after successful intubation
Time to Intubation
Time frame: Time of Induction through 2 minutes after successful intubation
Need for Assistance
Time frame: Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications
Time frame: Time of Induction through 2 minutes after successful intubation
Malposition of Endotracheal Tube
Time frame: Time of Induction through 2 minutes after successful intubation
Repositioning Patient
Time frame: Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality
Time frame: From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days
Time frame: From enrollment through study day 28
ICU-Free Days
Time frame: From enrollment through study day 28
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 19 Sep 2016.
- Derived from this study: PubMed 28917549Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Derived from this study: PubMed 28487139Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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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.
Todd W Rice, MD, MSc study director
Vanderbilt University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Written Checklist and Head of Bed Up in people with Respiratory Failure, run by Vanderbilt University at 5 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 6 inclusion and 4 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions) (time frame: Time of Induction through 2 minutes after successful intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02497729, which also lists 2 linked publications.
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 19 Sep 2016.