Sustained CPRNCT05616897
Physiological Responses During Sustained CPR.
A study testing Physiological responses during sustained CPR in people with Sustained CPR, run by University Ghent.
Trial summary
Background Since fatigue seems related to poorer physical fitness rather than to gender, we analyzed the physiological responses during a 30 minutes sustained CPR sequence. Methods and results Handgrip strength and VO2 max determined strength and endurance. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sustained CPR
- What is being tested?
- Physiological responses during sustained CPR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2012
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicine or Physical education student
Who cannot join
- hypertension arrhythmia failure to maintain correct compression rhythm or depth
About this study
Official title: Physiological Responses During a 30 Minutes Sustained CPR Sequence With Feedback in Female Rescuers: a Comparison Between Medicine and Physical Education Students.
Background Since fatigue seems related to poorer physical fitness rather than to gender, we analyzed the physiological responses during a 30 minutes sustained CPR sequence.
Methods and results Handgrip strength and VO2 max determined strength and endurance. Twenty-three medicine (M) and 27 physical education (PE) female students performed 30 minutes CPR. Compression quality and ECG were continuously monitored, heartrate and non-invasive blood pressure (NIBP) every 2 minutes. Capillary pH, PcCO2, lactate, potassium and sodium bicarbonate were analyzed every 10 minutes.
Read the detailed description
2.1. Data collection Fifty female students who completed a CPR course in accordance with the 2010 ERC Guidelines were recruited on a voluntary base at the faculty of Medicine and Health Sciences (Ghent University, Belgium). Given the reports of several authors that the physical characteristics of the rescuers (including gender) had no impact on their CPR performance, we did not use a male control group. This prospective data collection was carried out at Ghent University Hospital and approved by the research Ethics Committee (B670201112158) and informed consent was obtained from every participant.
2.2 Study protocol The participants were divided into two groups according to their expected physical condition: Medicine students (M; n=23) and Physical Education students (PE; n=27). As a consequence of their curriculum we expected the physical education students to have a good or at least better physical condition compared to the medical students. The participants' height (anthropometer GPM, DKSH Switzerland), weight (electronic SECA, 815 Elegantia) and body fat percentage (Harpende Skinfold Calliper, Fysio Supplies) were measured. Body mass index (BMI; kg/m²) was calculated. To assess baseline strength and endurance respectively, we measured hand grip strength (kg) (Hydraulic hand dynamometer, Sachon corporation, Mason) as a determinant of general muscle strength and we estimated maximal oxygen uptake (ml/kg/min) by means of an endurance shuttle run test as a parameter of maximal aerobic power.In order to detect unknown cardiac abnormalities a 12 lead ECG (Delta 60 plus, Cardioline) was performed in all volunteers.
All participants were considered as lay rescuers and had received previous CPR training. However, to avoid any pre-testing difference, each group received a CPR instruction booster, using the ERC-accredited 4-stage approach, one week before the study.
After this, the students were asked to perform a 30 minutes sustained CPR sequence (30:2). Regarding the available evidence on the impact of CPR feedback devices on CPR quality, participants were given real-time feedback on hand positioning, compression depth, ventilation volume and a metronome continuously provided a rhythm of 100-120 compressions per minute.(5) CPR quality data were registered using a Laerdal Resusci Anne manikin (Laerdal, Norway) connected to a Laerdal PC Skill reporting software (version 2.4) and simultaneously monitored by an observer.
To define compressions as adequate, they were automatically evaluated for depth (>5 cm), frequency (100-120/min) and complete release (<0.5 cm). The ventilations were automatically evaluated for the inflated volume (400-1000 ml). The 30:2 CPR was performed during 30 minutes with a hands-off period every 2 minutes during the AED analysis. This time interval was used to measure and register the volunteers heart rate (bpm), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2), which was repeated every 2 minutes. All participants were connected to a continuous 5 lead ECG monitor (SC 9000 xl, Siemens). In addition to the non invasive monitoring, capillary blood samples from the fingertip were taken every 10 minutes to analyze the pH, PcCO2, lactate, potassium and sodium bicarbonate (Radiometer ABL90 Flex, Denmark). The results of the non-invasive and capillary monitoring were evaluated by an anaesthesiologist and exercise physiologist throughout the whole exercise. In case of hypertension or arrhythmia, tiredness, feeling unwell or failure to maintain correct compression rhythm or depth the participant was asked to stop the physical effort and the reason was noted. At the end of the 30 minutes the participants were asked to appraise their feeling of exertion on a "Borg rating of perceived exertion scale" ranging from 6 to 20.
- Conditions
- Sustained CPR
- Being tested
- Physiological responses during sustained CPR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological responses during sustained CPRBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Medicine students | Other | students with normal expected fitness Receives: Behavioral: Physiological responses during sustained CPR |
| Physical education students | Other | students with better expected fitness Receives: Behavioral: Physiological responses during sustained CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood pressure between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Measured: 30 minutes
Difference in heart rate between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Measured: 30 minutes
Difference in respiration rate between female medicine and physical education students during a 30 minutes sustained CPR sequence
Measured: 30 minutes
Difference in pCO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Measured: 30 minutes
Difference in pO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Measured: 30 minutes
Difference in lactate values between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sustained CPRStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616897
- Sponsor's protocol ID
- B670201112158
- Status last verified
- Nov 2022
- First submitted
- 10 Feb 2015
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses During a 30 Minutes Sustained CPR Sequence With Feedback in Female Rescuers: a Comparison Between Medicine and Physical Education Students.
- ClinicalTrials.gov ID
- NCT05616897
- Acronym / sponsor ID
- B670201112158
- Conditions
- Sustained CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Nov 2022 (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.
Background Since fatigue seems related to poorer physical fitness rather than to gender, we analyzed the physiological responses during a 30 minutes sustained CPR sequence.
Methods and results Handgrip strength and VO2 max determined strength and endurance. Twenty-three medicine (M) and 27 physical education (PE) female students performed 30 minutes CPR. Compression quality and ECG were continuously monitored, heartrate and non-invasive blood pressure (NIBP) every 2 minutes. Capillary pH, PcCO2, lactate, potassium and sodium bicarbonate were analyzed every 10 minutes.
Detailed description
2.1. Data collection Fifty female students who completed a CPR course in accordance with the 2010 ERC Guidelines were recruited on a voluntary base at the faculty of Medicine and Health Sciences (Ghent University, Belgium). Given the reports of several authors that the physical characteristics of the rescuers (including gender) had no impact on their CPR performance, we did not use a male control group. This prospective data collection was carried out at Ghent University Hospital and approved by the research Ethics Committee (B670201112158) and informed consent was obtained from every participant.
2.2 Study protocol The participants were divided into two groups according to their expected physical condition: Medicine students (M; n=23) and Physical Education students (PE; n=27). As a consequence of their curriculum we expected the physical education students to have a good or at least better physical condition compared to the medical students. The participants' height (anthropometer GPM, DKSH Switzerland), weight (electronic SECA, 815 Elegantia) and body fat percentage (Harpende Skinfold Calliper, Fysio Supplies) were measured. Body mass index (BMI; kg/m²) was calculated. To assess baseline strength and endurance respectively, we measured hand grip strength (kg) (Hydraulic hand dynamometer, Sachon corporation, Mason) as a determinant of general muscle strength and we estimated maximal oxygen uptake (ml/kg/min) by means of an endurance shuttle run test as a parameter of maximal aerobic power.In order to detect unknown cardiac abnormalities a 12 lead ECG (Delta 60 plus, Cardioline) was performed in all volunteers.
All participants were considered as lay rescuers and had received previous CPR training. However, to avoid any pre-testing difference, each group received a CPR instruction booster, using the ERC-accredited 4-stage approach, one week before the study.
After this, the students were asked to perform a 30 minutes sustained CPR sequence (30:2). Regarding the available evidence on the impact of CPR feedback devices on CPR quality, participants were given real-time feedback on hand positioning, compression depth, ventilation volume and a metronome continuously provided a rhythm of 100-120 compressions per minute.(5) CPR quality data were registered using a Laerdal Resusci Anne manikin (Laerdal, Norway) connected to a Laerdal PC Skill reporting software (version 2.4) and simultaneously monitored by an observer.
To define compressions as adequate, they were automatically evaluated for depth (>5 cm), frequency (100-120/min) and complete release (<0.5 cm). The ventilations were automatically evaluated for the inflated volume (400-1000 ml). The 30:2 CPR was performed during 30 minutes with a hands-off period every 2 minutes during the AED analysis. This time interval was used to measure and register the volunteers heart rate (bpm), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2), which was repeated every 2 minutes. All participants were connected to a continuous 5 lead ECG monitor (SC 9000 xl, Siemens). In addition to the non invasive monitoring, capillary blood samples from the fingertip were taken every 10 minutes to analyze the pH, PcCO2, lactate, potassium and sodium bicarbonate (Radiometer ABL90 Flex, Denmark). The results of the non-invasive and capillary monitoring were evaluated by an anaesthesiologist and exercise physiologist throughout the whole exercise. In case of hypertension or arrhythmia, tiredness, feeling unwell or failure to maintain correct compression rhythm or depth the participant was asked to stop the physical effort and the reason was noted. At the end of the 30 minutes the participants were asked to appraise their feeling of exertion on a "Borg rating of perceived exertion scale" ranging from 6 to 20.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicine students | Other | Behavioral: Physiological responses during sustained CPRstudents with normal expected fitness |
| Physical education students | Other | Behavioral: Physiological responses during sustained CPRstudents with better expected fitness |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medicine or Physical education student
Key exclusion criteria (1 listed)
- hypertension arrhythmia failure to maintain correct compression rhythm or depth
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 |
|---|---|---|
| Physiological responses during sustained CPR | Behavioural | Medicine students, Physical education students |
Primary outcome
Difference in blood pressure between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Time frame: 30 minutes
Difference in heart rate between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Time frame: 30 minutes
Difference in respiration rate between female medicine and physical education students during a 30 minutes sustained CPR sequence
Time frame: 30 minutes
Difference in pCO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Time frame: 30 minutes
Difference in pO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Time frame: 30 minutes
Difference in lactate values between female medicine and physical education students during a 30 minutes sustained CPR sequence.
Time frame: 30 minutes
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 15 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological responses during sustained CPR in people with Sustained CPR, run by University Ghent.
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 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference in blood pressure between female medicine and physical education students during a 30 minutes sustained CPR sequence. (time frame: 30 minutes). The study lists 6 primary outcomes in all. 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 15 Nov 2022.