Ideal needle size and location for needle insertion to relieve a condition called tension pneumothorax, which can cause difficulty breathing. A study in an elite rugby team
| ISRCTN | ISRCTN14301076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14301076 |
- Submission date
- 08/03/2023
- Registration date
- 04/04/2023
- Last edited
- 04/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Tension pneumothorax is a very rare event, but a medical emergency. It can happen if there is damage to the lung causing a leak. Air can escape from the lung, into the space between the chest wall and outside of the lung. If air continues to accumulate from the lung in this space, it can compress the lung and the heart. This can then significantly compromise heart and lung function. If this happens out of hospital, a small needle with surrounding tubing (a cannula) can be inserted into the space between the chest wall and lung. The needle is then withdrawn, leaving the tubing which can relieve this tension, and allow better functioning of the heart and lung and allow transfer to hospital.
Previous guidance unanimously recommended carrying out the cannula insertion procedure near the top of the chest. However, research is really mixed as to the best place, and now some guidance suggests carrying out the procedure to the side of the chest. These recommendations are for the general population. There is also a discrepancy of the optimal cannula length to use.
Professional rugby players are very likely to have increased muscle bulk over the chest wall, which previous research has shown. The study aims to take measurements of the chest wall thickness, which may help future guidance on recommendations of the best place to carry out this (very unlikely) procedure.
We are also interested in seeing if there is any correlation between the size of the chest and upper arm and chest wall thickness, which may help identify players where a longer needle may be needed.
The final measurement we will take is the distance from the skin to important structures such as the heart, again to help look at risks by using different approaches and helping research cannula length.
Who can participate?
Professional rugby (union) players aged over 18 years
What does the study involve?
Measurements of the chest wall thickness (with an ultrasound scan), the size of the chest and upper arm and chest wall thickness (with a tape measure), and distance from the skin to important structures such as the heart (using ultrasound).
What are the possible benefits and risks of participating?
Benefit of contributing to research that may save lives.
No risks.
Where is the study run from?
Jersey Sports Medicine and Shockwave Clinic (Jersey)
When is the study starting and how long is it expected to run for?
March 2023 to June 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr David Howell
Contact information
Principal Investigator
Jersey Sports Medicine and Shockwave Clinic
Health Plus
Queens Road
St Helier
JE2 4HY
Jersey
 ORCID ID |
0009-0006-7927-3432 |
|---|---|
| Phone | +44 7797821932 |
| dave@jerseysportsmedicine.je |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Fitness/sport facility |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Optimal size and needle position for needle decompression in tension pneumothorax: Observational study in an elite rugby team |
| Study acronym | OSANP |
| Study hypothesis | Professional rugby union player size has continued to increase over an 8-year period, which may lead to an increase in failure of needle decompression (NT), in either the 2nd intercostal space, mid clavicular line(2ICS), or 4th/5th intercostal space, just anterior to either the mid axillary or anterior axillary line, (4/5ICS) using a standard 45mm catheter. In an athletic population, pectoral muscle mass will likely be increased in the 2ICS leading to increased chest wall thickness. There is a risk of failure of NT in tension pneumothorax, and the 4/5ICS is the preferred initial management. There is correlation between chest circumference or upper arm circumference and CWT in elite rugby players and this could help identify players in the team that may have an increased CWT and where a longer catheter should be considered. Replacing the 14G catheter with a longer, purposely made catheters for all, will increase iatrogenic risk. |
| Ethics approval(s) | Approval pending, Health and Community Services, Jersey, Research Ethics Committee |
| Condition | Optimal position for needle decompression in tension pneumothorax and assessment of iatrogenic risk in a male professional rugby team. |
| Intervention | We will use ultrasound to take measurements from the skin to pleural line in the 2nd intercostal space, mid clavicular line, and 4/5th intercostal space, just anterior to the anterior axillary line and just anterior to mid axillary line, along with measurements from here to the pericardium in expiration, and systolic phase of the cardiac cycle. Also, we will take measurements of upper arm and chest circumference to see if there is any correlation with chest wall thickness (CWT). Ultrasound examination will then take place with the patient lying supine on an examination couch, with the arms relaxed by the side. This will be done using a GE loqiq E ultrasound machine, using an 8-12Mhz probe in the appropriate setting for the depth. Gel stand-off will be used to capture images, to ensure there is no compression of the chest wall. Images will be captured, and recorded for review, and measurements taken from the skin to the pleural line and entered an excel file. A cardiology consultant, highly experienced in imaging will also take measurements from the skin to the pericardium, after capturing an image in the systolic phase in the lateral chest positions. This measurement will be performed in expiration, as this is likely to give the best echo windows and shortest distance (therefore greatest iatrogenic risk). However, there may be some variability depending upon echo windows. In some cases, we might also need to reposition the player into a left lateral position rather than prone to obtain good echo window and measurement. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ultrasound |
| Primary outcome measure | Chest wall thickness measured by ultrasound between the 2ICS MCL, and 4/5 ICS AAL, and 5ICS MCL at a single time point |
| Secondary outcome measures | Measured at a single time point: 1. Upper arm circumference and chest circumference (with tape measure) 2. Potential of iatrogenic risk (measured with ultrasound from the skin to the pericardium) |
| Overall study start date | 08/03/2023 |
| Overall study end date | 01/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30-40 |
| Participant inclusion criteria | 1. Adult players (aged >18 years) 2. Part of a professional rugby team 3. Male |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/05/2023 |
| Recruitment end date | 02/05/2023 |
Locations
Countries of recruitment
- Jersey
Study participating centre
Jersey
JE3 7BG
Jersey
Sponsor information
Hospital/treatment centre
Jersey General Hospital
St Helier
JE1 3QS
Jersey
| Phone | +44 7797 739831 |
|---|---|
| austin@theallanlab.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, potentially the British Journal of Sports Medicine |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr David Howell - dave@jerseysportsmedicine.je |
Editorial Notes
04/04/2023: Trial's existence confirmed by Government of Jersey
