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Sustained CPRNCT05616897

Physiological Responses During Sustained CPR.

A study testing Physiological responses during sustained CPR in people with Sustained CPR, run by University Ghent.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT05616897
Study groupRoleWhat they receive
Medicine studentsOtherstudents with normal expected fitness
Receives: Behavioral: Physiological responses during sustained CPR
Physical education studentsOtherstudents 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.

  1. Difference in blood pressure between female medicine and physical education students during a 30 minutes sustained CPR sequence.

    Measured: 30 minutes

  2. Difference in heart rate between female medicine and physical education students during a 30 minutes sustained CPR sequence.

    Measured: 30 minutes

  3. Difference in respiration rate between female medicine and physical education students during a 30 minutes sustained CPR sequence

    Measured: 30 minutes

  4. Difference in pCO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.

    Measured: 30 minutes

  5. Difference in pO2 between female medicine and physical education students during a 30 minutes sustained CPR sequence.

    Measured: 30 minutes

  6. 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.

  1. First posted15 Nov 2022
  2. Study startOct 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

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)
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

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.

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