Blood Gas AnalysisNCT02320916
A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture
A study testing 23Gauge and 25Gauge in people with Blood Gas Analysis and Pain, run by University Hospital, Rouen at 1 site in France.
Trial summary
Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Gas Analysis, Pain
- What is being tested?
- 23Gauge and 25Gauge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to May 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who had a planned assessment of arterial blood gas in our Respiratory Department
Who cannot join
- under the age of 18
- inability to provide consent
- the presence of a contraindication to arterial punctures based on the American Association of Respiratory Care Guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. The only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. However, this technique is more time consuming and is poorly used.
Topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy.
Read more
While performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain.
The aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.
- Conditions
- Blood Gas Analysis, Pain
- Being tested
- 23Gauge, 25Gauge
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23GaugeProcedure or surgery
Arterial puncture will be made using a 23Gauge needle
25GaugeProcedure or surgery
Arterial puncture will be made using a 25Gauge needle
| Study group | Role | What they receive |
|---|---|---|
| 23Gauge | Active comparator | Arterial blood puncture will be performed using a 23Gauge needle Receives: Procedure: 23Gauge |
| 25Gauge | Active comparator | Arterial blood puncture will be performed using a 25Gauge needle Receives: Procedure: 25Gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced by the patient during arterial puncture
Evaluated using a Visual Analogue Scale for pain. Graduated from 0 to 100mm
Measured: Less thant 60minutes after puncture
Secondary outcomes (3)
Anxiety before and after puncture arterial puncture
Evaluated using a Visual Analogue Scale for anxiety. Graduated from 0 to 100mm
Measured: Before puncture and less than 60minutes after puncture
Most painful moment of the arterial puncture
Evaluated by a standardised questionnaire: The most painful moment was :
A/ At needle insertion B/ During puncture C/ After puncture D/ While the puncture was repeated
Measured: Less than 60minutes after puncture
Duration of arterial puncture
Time needed to perform the procedure will be evaluated using a chronometer. The number of seconds needed to collect the arterial blood gas will we recorded.
Measured: 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Gas AnalysisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouchra Lamia, MD, MPH, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320916
- Sponsor's protocol ID
- 2010/191/SC
- Status last verified
- Aug 2016
- First submitted
- 10 Dec 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015.
PubMed 26407017
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture
- ClinicalTrials.gov ID
- NCT02320916
- Acronym / sponsor ID
- 2010/191/SC
- Conditions
- Blood Gas Analysis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. The only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. However, this technique is more time consuming and is poorly used.
Topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy.
While performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain.
The aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 23Gauge | Active comparator | Procedure: 23GaugeArterial blood puncture will be performed using a 23Gauge needle |
| 25Gauge | Active comparator | Procedure: 25GaugeArterial blood puncture will be performed using a 25Gauge needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who had a planned assessment of arterial blood gas in our Respiratory Department
Key exclusion criteria (3 listed)
- under the age of 18
- inability to provide consent
- the presence of a contraindication to arterial punctures based on the American Association of Respiratory Care Guidelines
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 |
|---|---|---|
| 23GaugeArterial puncture will be made using a 23Gauge needle | Procedure or surgery | 23Gauge |
| 25GaugeArterial puncture will be made using a 25Gauge needle | Procedure or surgery | 25Gauge |
Primary outcome
Pain experienced by the patient during arterial puncture
Time frame: Less thant 60minutes after puncture
Evaluated using a Visual Analogue Scale for pain. Graduated from 0 to 100mm
3 secondary outcomes
Anxiety before and after puncture arterial puncture
Time frame: Before puncture and less than 60minutes after puncture
Most painful moment of the arterial puncture
Time frame: Less than 60minutes after puncture
Duration of arterial puncture
Time frame: 10minutes
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 17 Aug 2016.
- Derived from this study: PubMed 26407017Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015.
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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.
Bouchra Lamia, MD, MPH, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 23Gauge and 25Gauge in people with Blood Gas Analysis and Pain, run by University Hospital, Rouen at 1 site in France.
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 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 17 Aug 2016. 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 France. 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?
Pain experienced by the patient during arterial puncture (time frame: Less thant 60minutes after puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320916, which also lists 1 linked publication.
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 17 Aug 2016.