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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03784664
Other study ID # Assistance Publique - Hôpitaux
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2019
Est. completion date March 22, 2019

Study information

Verified date December 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas.

Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices.

The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 22, 2019
Est. primary completion date March 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- necessity of blood gas analysis

- age > 18 yo

- SpO2>95% without supplemental oxygen

- no altered level of consciousness: Glasgow Coma Scale=15

Exclusion Criteria:

- Patient under guardianship or curatorship

- confusional state or patient unable to understand the protocol

- no social security

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Arterial blood gas
arterial blood sample with puncture of the radial artery
Veinous blood gas
veinous blood sample using peripheral venepuncture

Locations

Country Name City State
France Hôpital Beaujon Clichy
France Hôpital Louis Mourier Colombes
France Hôpital Bichat Paris
France Hôpital Lariboisière Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score: Visual Analog Scale Pain is self-completed by the patient using a Visual Analog Scale. Visual Analog Scale for Pain is a continuous scale comprised of a line of 100 mm grading pain intensity anchored by "no pain" (score 0) and "worst imaginable pain" (score 100) Immediately after blood gas sample
Secondary Number of attempts needed to obtain a blood gas sample Immediately after blood gas sample
Secondary Number of different operators needed to obtain a blood gas sample Immediately after blood gas sample
Secondary Ease of blood gas sampling procedure Ease of blood gas sampling procedure assessed by the operator using a four-levels likert scale ("easy","moderate","difficult" "very difficult") Immediately after blood gas sample
Secondary Failure of the blood gas sampling procedure Impossibility to obtain a blood gas sample Immediately after blood gas sample
Secondary Quality of information provided by the blood gas analysis: four levels likert scale Four-levels likert scale assessing doctor's satisfaction regarding the quality of gas information provided by the blood gas analysis ("very satisfied","satisfied","slightly satisfied","not satisfied" Immediately after having received blood gas analysis results
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