Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual VentilationNCT03544164
Assessing Respiratory Rate and Tidal Volume Delivery During Manual Ventilation
An observational study of Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual Ventilation, run by Rush University Medical Center at 1 site in United States.
Trial summary
Excessive minute ventilation for patients who experience cardiac arrest may cause pulmonary injury and decrease the overall effectiveness of cardiopulmonary resuscitation (CPR). Although clinicians are trained with the correct technique for manual ventilation, evidence still shows that clinicians tend to deliver a… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual Ventilation
- What is being tested?
- Manual Ventilation
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 7 Jul 2019
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: Medical professionals attending an American Heart Association Advanced Cardiac Life Support course
Who may be able to join
- 21 years old or older
- licensed clinician, regardless of medical profession
Who cannot join
- Full-time, non-licensed students that have no completed their formal training program at Rush University
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60187
About this study
Excessive minute ventilation for patients who experience cardiac arrest may cause pulmonary injury and decrease the overall effectiveness of cardiopulmonary resuscitation (CPR). Although clinicians are trained with the correct technique for manual ventilation, evidence still shows that clinicians tend to deliver a higher respiratory rate than recommended during CPR. Little is known about tidal volume delivery during CPR; either the amount of volume give or even the impact of tidal volume on the effectiveness of CPR. There are many factors that may influence variations of tidal volumes and RR during CPR. These factors include distractions in the room (noise/cross talk), inability to assess tidal volume delivery, anxiety, and stress of the situation. This study will evaluate tidal volume and respiratory rate (RR) delivery during a simulated CPR situation. Participants will be asked to provide care for an intubated adult patient in cardiac arrest, which will include all components of advanced cardiac life support training.
Read the detailed description
This will be a cross-sectional study, conducted during regularly scheduled ACLS courses at Rush University Medical Center. Enrollment will be by random assignment as participants arrive for the ACLS course. Those that consent to the study will be informed that the investigator's study is to observe ACLS performance, but the exact parameters being measured will not be disclosed in an effort to mitigate any changes in behaviors.
During the course of the study, groups will be assigned sequentially, and the first group to participate will be termed as "Group 1". Within the group, each participant will be assigned a letter to identify the sequence of rotation with the skills. For example, the first participant in group 1 to perform manual ventilation will be assigned the study identity of "1A". The second person in the first group will be "1B", and so on.
During the ACLS megacode component of the ACLS training, each study participant will be given the opportunity to manually ventilate the simulated intubated adult patient, as per the normal rotation during a megacode. During the megacode, information will be collected via the NICO2 Respiratory Management System (Philips Respironics, Murrysville, Pennsylvania) that is attached to the endotracheal tube, which will be video recorded, as this system does not have function of data storage or downloaded. This is to assure each breath is captured so the study team can assure accuracy of data collection. None of the study participants will be video recorded.
At the completion of the study, each participant will be debriefed on their performance and informed of the true nature of the study; which is to evaluate respiratory rate and tidal volume delivery during manual ventilation to an intubated patient during an ACLS rescue attempt.
- Conditions
- Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual Ventilation
- Being tested
- Manual Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual VentilationOther
Manual ventilation via endotracheal tube using adult manual resuscitation device
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume delivery
Amount of volume delivered in milliliters per squeeze of the resuscitation device
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start7 May 2018
- Primary completion7 Jul 2019
- Study completion7 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual VentilationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brady Scott, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544164
- Sponsor's protocol ID
- 18020603
- Status last verified
- Sep 2019
- First submitted
- 21 May 2018
- Last updated
- 10 Sep 2019
- Results posted
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Respiratory Rate and Tidal Volume Delivery During Manual Ventilation
- ClinicalTrials.gov ID
- NCT03544164
- Acronym / sponsor ID
- 18020603
- Conditions
- Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 1 Jun 2018 (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.
Excessive minute ventilation for patients who experience cardiac arrest may cause pulmonary injury and decrease the overall effectiveness of cardiopulmonary resuscitation (CPR). Although clinicians are trained with the correct technique for manual ventilation, evidence still shows that clinicians tend to deliver a higher respiratory rate than recommended during CPR. Little is known about tidal volume delivery during CPR; either the amount of volume give or even the impact of tidal volume on the effectiveness of CPR. There are many factors that may influence variations of tidal volumes and RR during CPR. These factors include distractions in the room (noise/cross talk), inability to assess tidal volume delivery, anxiety, and stress of the situation. This study will evaluate tidal volume and respiratory rate (RR) delivery during a simulated CPR situation. Participants will be asked to provide care for an intubated adult patient in cardiac arrest, which will include all components of advanced cardiac life support training.
Detailed description
This will be a cross-sectional study, conducted during regularly scheduled ACLS courses at Rush University Medical Center. Enrollment will be by random assignment as participants arrive for the ACLS course. Those that consent to the study will be informed that the investigator's study is to observe ACLS performance, but the exact parameters being measured will not be disclosed in an effort to mitigate any changes in behaviors.
During the course of the study, groups will be assigned sequentially, and the first group to participate will be termed as "Group 1". Within the group, each participant will be assigned a letter to identify the sequence of rotation with the skills. For example, the first participant in group 1 to perform manual ventilation will be assigned the study identity of "1A". The second person in the first group will be "1B", and so on.
During the ACLS megacode component of the ACLS training, each study participant will be given the opportunity to manually ventilate the simulated intubated adult patient, as per the normal rotation during a megacode. During the megacode, information will be collected via the NICO2 Respiratory Management System (Philips Respironics, Murrysville, Pennsylvania) that is attached to the endotracheal tube, which will be video recorded, as this system does not have function of data storage or downloaded. This is to assure each breath is captured so the study team can assure accuracy of data collection. None of the study participants will be video recorded.
At the completion of the study, each participant will be debriefed on their performance and informed of the true nature of the study; which is to evaluate respiratory rate and tidal volume delivery during manual ventilation to an intubated patient during an ACLS rescue attempt.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medical professionals attending an American Heart Association Advanced Cardiac Life Support course
Key inclusion criteria (2 listed)
- 21 years old or older
- licensed clinician, regardless of medical profession
Key exclusion criteria (1 listed)
- Full-time, non-licensed students that have no completed their formal training program at Rush University
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 |
|---|---|---|
| Manual VentilationManual ventilation via endotracheal tube using adult manual resuscitation device | Other | – |
Primary outcome
Tidal Volume delivery
Time frame: through study completion, an average of 1 year
Amount of volume delivered in milliliters per squeeze of the resuscitation device
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 10 Sep 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual Ventilation, run by Rush University Medical Center at 1 site 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 2 inclusion and 1 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Tidal Volume delivery (time frame: through study completion, an average of 1 year). 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 10 Sep 2019.