Cardiac Output, HighNCT04111237
Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation
A study testing Two Finger technique and Two Thumb Technique in people with Cardiac Output, High, run by University College Cork at 1 site in Ireland.
Trial summary
The majority of newborns transition successfully from intrauterine to extrauterine life without any assistance. Less than 1% of all newborns will require extensive neonatal resuscitation involving chest compressions (CC) and medications at birth 1. Read more about this study
- Who is it for?
- Ages 24 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output, High
- What is being tested?
- Two Finger technique and Two Thumb Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 28 Jun 2018to 30 Aug 2018
- Phase
- Interventional
- 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 24 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Neonatology NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology
Who cannot join
- Any history of cardiac or respiratory disorder
- Physicians who are post-call/sleep deprived
- Pregannt
Trial locations and contacts
1 site in 1 country.
About this study
The majority of newborns transition successfully from intrauterine to extrauterine life without any assistance. Less than 1% of all newborns will require extensive neonatal resuscitation involving chest compressions (CC) and medications at birth 1. Chest compressions are indicated for those newborns whose heart rate remains less than 60 beats per minute despite adequate ventilation 1. The American Heart Association (AHA) identifies two different methods of delivering chest compressions; a) the two-thumb (TT) method and b) the two-finger (TF) method. The two-thumb method is favoured by the AHA as it results in higher blood pressure and coronary perfusion pressures and can also be delivered from the head of the bed during umbilical catheter insertion 1.
The quality of CC plays a vital role in delivering effective cardiopulmonary resuscitation (CPR). Solevag et al. report that high-quality CC requires (A) optimal compression:ventilation (C:V) ratio, (B) adequate CC rate, (C) depth of CC as well as (D) full recoil between compressions 2. The American Heart Association (AHA) recommend delivering chest compressions on the lower third of the sternum to a depth of one third the anterior-posterior (AP) chest diameter. The recommended C:V ratio is 3:1 (90 compressions and 30 breaths per minute) 1.
Read more
A number of studies have highlighted the effects of rescuer fatigue on quality of chest compressions. One study reported adverse effects on CC quality when performed without interruption over a 3 minute period 6. It has therefore been recommended to rotate rescuers every 2-3 minutes in order to avoid rescuer fatigue and to ensure high quality CC6-7. As well as duration of CC, other factors can contribute to greater levels of rescuer fatigue. A number of studies have looked at the effect of different CC to ventilation methods on rescuer fatigue. Bodingh et al investigated this during simulated infant CPR. They reported greater levels of rescuer fatigue during simulated CPR in CCaV (continuous CC with asynchronous ventilation) at 120 CC per min compared to the recommended 3:1 C:V CPR 3. A similar study was performed by Li et al where rescuer fatigue was assessed during (i) 3:1 C:V ratio, (ii) CCaV at 90 CC per min and (iii) CCaV at 120 CC per min. However, unlike Bodingh et al, they found both 3:1 C:V and CCaV CPR to be equally fatiguing 4. Different CC techniques (TT vs TF method) can also cause varying levels of rescuer fatigue. In a recent study, Jiang et al compared the TT and TF chest compression techniques on infant mannequins and found that the TF method caused greater levels of rescuer fatigue compared with the TT method 5. We therefore set out to investigate whether different CC techniques cause different levels of rescuer fatigue during neonatal CPR. We hypothesize that performing TF method on neonatal mannequins will produce greater levels of rescuer fatigue. The results of this study would have significant implications in terms of choice of CC technique in new-born resuscitation.
The purpose of this study is to compare rescuer fatigue during simulated neonatal chest compressions using two different CC methods; the two-finger (TF) method vs two-thumb (TT) method. This will be performed on both preterm and term mannequins by neonatologists and level of fatigue will be assessed by measuring change in cardiac output during chest compressions.
Hypothesis: Performing CC using the two-finger (TF) method produces higher levels of rescuer fatigue compared with the two-thumb (TT) method during 5 minutes of simulated neonatal CPR.
Read the detailed description
Inclusion criteria
- Neonatology NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology Exclusion criteria
- Any history of cardiac or respiratory disorder 2. Physicians who are post-call/sleep deprived
Intervention:
This will be a crossover trial. Each participant will be assigned to performing ether TT or TF chest compressions. The participant will each perform 5 minutes of simulated chest compressions either a term or preterm mannequin using 3:1 C:V CPR. Each participant will have NICOM leads attached to their body which will record HR and cardiac output. One week later the participant will cross over and perform the alternate CC technique. The trial will initially be performed on a term mannequin for the first 2 weeks before being repeated on a preterm mannequin.
Data Collection:
Recorded data will include: Age, gender, ethnicity, weight, height, BMI, HR and cardiac output. Participants will have an allocated study number, ensuring that the data collected will be anonymised. The list of study numbers and data will be stored in a secure password protected database in the Neonatal Unit. Only people involved in the study and other authorised persons will have access to this information.
Outcome Measures:
Primary Outcome Measure:
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.
Secondary Outcome Measure:
Perceived level of fatique. At the end of the study session each subject will complete a Likert scale-based questionnaire on subjective feeling of fatigue.
- Conditions
- Cardiac Output, High
- Being tested
- Two Finger technique, Two Thumb Technique
- Medical subject headings
- Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Finger techniqueBehavioural
two finger method for chest compression provuision
Two Thumb TechniqueBehavioural
Two thumb technique
| Study group | Role | What they receive |
|---|---|---|
| Two Finger | Active comparator | two finger method for performing chest compressions Receives: Behavioral: Two Thumb Technique |
| Two Thumb Technique | Experimental | Two Thumb Technique Receives: Behavioral: Two Finger technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR
using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start28 Jun 2018
- Primary completion30 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, HighStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111237
- Sponsor's protocol ID
- ECM 4(ff) 07/03/18
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2018
- Last updated
- 24 Jun 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation
- ClinicalTrials.gov ID
- NCT04111237
- Acronym / sponsor ID
- ECM 4(ff) 07/03/18
- Conditions
- Cardiac Output, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 1 Oct 2019 (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.
The majority of newborns transition successfully from intrauterine to extrauterine life without any assistance. Less than 1% of all newborns will require extensive neonatal resuscitation involving chest compressions (CC) and medications at birth 1. Chest compressions are indicated for those newborns whose heart rate remains less than 60 beats per minute despite adequate ventilation 1. The American Heart Association (AHA) identifies two different methods of delivering chest compressions; a) the two-thumb (TT) method and b) the two-finger (TF) method. The two-thumb method is favoured by the AHA as it results in higher blood pressure and coronary perfusion pressures and can also be delivered from the head of the bed during umbilical catheter insertion 1.
The quality of CC plays a vital role in delivering effective cardiopulmonary resuscitation (CPR). Solevag et al. report that high-quality CC requires (A) optimal compression:ventilation (C:V) ratio, (B) adequate CC rate, (C) depth of CC as well as (D) full recoil between compressions 2. The American Heart Association (AHA) recommend delivering chest compressions on the lower third of the sternum to a depth of one third the anterior-posterior (AP) chest diameter. The recommended C:V ratio is 3:1 (90 compressions and 30 breaths per minute) 1.
A number of studies have highlighted the effects of rescuer fatigue on quality of chest compressions. One study reported adverse effects on CC quality when performed without interruption over a 3 minute period 6. It has therefore been recommended to rotate rescuers every 2-3 minutes in order to avoid rescuer fatigue and to ensure high quality CC6-7. As well as duration of CC, other factors can contribute to greater levels of rescuer fatigue. A number of studies have looked at the effect of different CC to ventilation methods on rescuer fatigue. Bodingh et al investigated this during simulated infant CPR. They reported greater levels of rescuer fatigue during simulated CPR in CCaV (continuous CC with asynchronous ventilation) at 120 CC per min compared to the recommended 3:1 C:V CPR 3. A similar study was performed by Li et al where rescuer fatigue was assessed during (i) 3:1 C:V ratio, (ii) CCaV at 90 CC per min and (iii) CCaV at 120 CC per min. However, unlike Bodingh et al, they found both 3:1 C:V and CCaV CPR to be equally fatiguing 4. Different CC techniques (TT vs TF method) can also cause varying levels of rescuer fatigue. In a recent study, Jiang et al compared the TT and TF chest compression techniques on infant mannequins and found that the TF method caused greater levels of rescuer fatigue compared with the TT method 5. We therefore set out to investigate whether different CC techniques cause different levels of rescuer fatigue during neonatal CPR. We hypothesize that performing TF method on neonatal mannequins will produce greater levels of rescuer fatigue. The results of this study would have significant implications in terms of choice of CC technique in new-born resuscitation.
The purpose of this study is to compare rescuer fatigue during simulated neonatal chest compressions using two different CC methods; the two-finger (TF) method vs two-thumb (TT) method. This will be performed on both preterm and term mannequins by neonatologists and level of fatigue will be assessed by measuring change in cardiac output during chest compressions.
Hypothesis: Performing CC using the two-finger (TF) method produces higher levels of rescuer fatigue compared with the two-thumb (TT) method during 5 minutes of simulated neonatal CPR.
Detailed description
Inclusion criteria
- Neonatology NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology Exclusion criteria
- Any history of cardiac or respiratory disorder 2. Physicians who are post-call/sleep deprived
Intervention:
This will be a crossover trial. Each participant will be assigned to performing ether TT or TF chest compressions. The participant will each perform 5 minutes of simulated chest compressions either a term or preterm mannequin using 3:1 C:V CPR. Each participant will have NICOM leads attached to their body which will record HR and cardiac output. One week later the participant will cross over and perform the alternate CC technique. The trial will initially be performed on a term mannequin for the first 2 weeks before being repeated on a preterm mannequin.
Data Collection:
Recorded data will include: Age, gender, ethnicity, weight, height, BMI, HR and cardiac output. Participants will have an allocated study number, ensuring that the data collected will be anonymised. The list of study numbers and data will be stored in a secure password protected database in the Neonatal Unit. Only people involved in the study and other authorised persons will have access to this information.
Outcome Measures:
Primary Outcome Measure:
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.
Secondary Outcome Measure:
Perceived level of fatique. At the end of the study session each subject will complete a Likert scale-based questionnaire on subjective feeling of fatigue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two Finger | Active comparator | Behavioral: Two Thumb Techniquetwo finger method for performing chest compressions |
| Two Thumb Technique | Experimental | Behavioral: Two Finger techniqueTwo Thumb Technique |
Who may qualify
- Ages
- 24 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Neonatology NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology
Key exclusion criteria (3 listed)
- Any history of cardiac or respiratory disorder
- Physicians who are post-call/sleep deprived
- Pregannt
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 |
|---|---|---|
| Two Finger techniquetwo finger method for chest compression provuision | Behavioural | Two Thumb Technique |
| Two Thumb TechniqueTwo thumb technique | Behavioural | Two Finger |
Primary outcome
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR
Time frame: 1 month
using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.
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 24 Jun 2020.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Two Finger technique and Two Thumb Technique in people with Cardiac Output, High, run by University College Cork at 1 site in Ireland.
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 3 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 24 Jun 2020. 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 Ireland. 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?
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR (time frame: 1 month). 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 24 Jun 2020.