Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05022290
Status:
RECRUITING
Last Update Posted:
2023-03-17
First Post:
2021-08-21
Brief Title:
Double-syringe vs Single-syringe Technique of Adenosine for Termination of Regular Narrow Complex Tachycardia
Sponsor:
Khon Kaen University
Organization:
Khon Kaen University
Study Overview
Official Title:
Comparison of Double-syringe vs Single-syringe Technique of Adenosine Administration for Termination of Regular-narrow Complex Tachycardia A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias It uses as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias The conventional method of adenosine administration is the double syringe technique DST However it consumes a lot of resources including two syringes a stopcock an extension tube and needs 2 nurses to administer An observational study found that a single syringe technique adenosine diluted with normal saline up to 20 ml was as effective as a double syringe technique However there is no randomized control trial for proving its efficacy
Detailed Description:
Supraventricular tachycardia SVT is the most common tachyarrhythmias in young adults children and infants The most common type in adults is the atrioventricular nodal reentrant tachycardia AVNRT and the incidence is 35 per 10000 person-years or 229 per 1000 persons
The treatment approach of SVT is based on hemodynamical stability The synchronized cardioversion is recommended for hemodynamically unstable patients on the other hand the vagal maneuvers and medications are considered for patients with stable hemodynamic
To date the 2019 ESC guideline for the management of supraventricular tachycardia stated that adenosine is still the first medication for acute therapy in patients with SVT if the vagal maneuver fails or is contraindicated A systematic review in 2021 showed that adenosine is equally efficacious for treating SVT but it is safer than intravenous calcium channel blockers due to a shorter half-life
Few studies reported that the effectiveness of conventional vagal maneuvers namely carotid sinus massage in SVT termination was around 19 to 54 when properly done The enhanced method of vagal maneuver or named the modified syringe technique was performed by blowing into a 10 mL syringe to move the plunger the success conversion rate of SVT was a little better than the convention technique 43 vs 17 Therefore adenosine is still crucial in the acute therapy of SVT in an emergency setting
Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias It was used as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias and it is also helpful in treating some type of regular wide QRS complex tachyarrhythmias differentiate between SVT with aberrancybundle branch block and ventricular tachycardia
Adenosine an endogenous purine nucleoside is the first drug of choice to terminate SVT The pharmacological response of adenosine is mediated through cardiac adenosine type 1 A1 receptors and has a dose-response relationship It prolongs atrioventricular AV conduction and results in transient AV block that is responsible for tachyarrhythmia termination The dosages for the peripheral intravascular IV route are 6 mg and follow by 12 mg if the first dose is failed2 To achieve rhythm conversion the injection should be performed as a rapid bolus with immediate saline flush through large veins eg antecubital in 1-2 seconds because adenosine is rapidly metabolized by enzymatic deamination to inactive inosine within seconds and achieve end-organ effects within 20-30 seconds2 This conventional method of adenosine administration is well-known as the double syringe technique DST The repeat dose is safe when administered at least 1 minute after the first dose The success rate of adenosine in terminating SVT was greater than 90 approximately
The potential side effects of adenosine are transient AV block flushing chest pain or dyspnea AF can be initiated or worsened in case of preexcitation existing premature ventricular tachycardias PVCsventricular tachycardia VT bronchospasm rare or coronary steal5 In addition Adenosine should be excluded or used with caution in patients with these conditions eg AV block greater than first degree or sinoatrial SA node dysfunction reactive airway disease concomitant use of verapamil or digoxin and Wolff-Parkinson-White WPW syndrome5
The DST requires a two-way stopcock which may not stock in some workplaces eg emergency medical services EMS and need the nursing staff to coordinate their actions administering the drug and flush simultaneously In the real world small hospitals had a transient shortage of medical equipment supply eg syringes The convenient method which combined adenosine and 15 mL of normal saline in one syringe was firstly proposed in the non-blind randomized prospective study between 1999 to 2001 and published the full original article in the Korean language since 2003 by Choi SC et al This trial demonstrated the success rate of the convenient method was higher than the standard method 857 vs 80 but its not statistically significant in addition the average of total administering doses and the complication of the convenient and standard method was not statistically different
Nearly two decades later Marc McDowell et al conducted a single-center prospective observational study with setting a 20 non-inferiority margin demonstrated that the successful conversion of SVT in the first dose 731 vs 407 and up to three doses 100 vs 704 in the single syringe technique SST and DST respectively And they didnt found any serious adverse effects eg dyspnea bradycardia or asystole Unfortunately superiority testing was not performed due to the limiting sample size
Therefore we hypothesized that the SST is non-inferior to the DST for terminating stable SVT by comparison a rate of successful conversion of SVT at the first 6 mg-dose of adenosine and the total average dosage of adenosine administered And we also aimed to compare the rate of side effects between both techniques of intravenous adenosine in those diagnosed with stable SVT
The treatment approach of SVT is based on hemodynamical stability The synchronized cardioversion is recommended for hemodynamically unstable patients on the other hand the vagal maneuvers and medications are considered for patients with stable hemodynamic
To date the 2019 ESC guideline for the management of supraventricular tachycardia stated that adenosine is still the first medication for acute therapy in patients with SVT if the vagal maneuver fails or is contraindicated A systematic review in 2021 showed that adenosine is equally efficacious for treating SVT but it is safer than intravenous calcium channel blockers due to a shorter half-life
Few studies reported that the effectiveness of conventional vagal maneuvers namely carotid sinus massage in SVT termination was around 19 to 54 when properly done The enhanced method of vagal maneuver or named the modified syringe technique was performed by blowing into a 10 mL syringe to move the plunger the success conversion rate of SVT was a little better than the convention technique 43 vs 17 Therefore adenosine is still crucial in the acute therapy of SVT in an emergency setting
Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias It was used as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias and it is also helpful in treating some type of regular wide QRS complex tachyarrhythmias differentiate between SVT with aberrancybundle branch block and ventricular tachycardia
Adenosine an endogenous purine nucleoside is the first drug of choice to terminate SVT The pharmacological response of adenosine is mediated through cardiac adenosine type 1 A1 receptors and has a dose-response relationship It prolongs atrioventricular AV conduction and results in transient AV block that is responsible for tachyarrhythmia termination The dosages for the peripheral intravascular IV route are 6 mg and follow by 12 mg if the first dose is failed2 To achieve rhythm conversion the injection should be performed as a rapid bolus with immediate saline flush through large veins eg antecubital in 1-2 seconds because adenosine is rapidly metabolized by enzymatic deamination to inactive inosine within seconds and achieve end-organ effects within 20-30 seconds2 This conventional method of adenosine administration is well-known as the double syringe technique DST The repeat dose is safe when administered at least 1 minute after the first dose The success rate of adenosine in terminating SVT was greater than 90 approximately
The potential side effects of adenosine are transient AV block flushing chest pain or dyspnea AF can be initiated or worsened in case of preexcitation existing premature ventricular tachycardias PVCsventricular tachycardia VT bronchospasm rare or coronary steal5 In addition Adenosine should be excluded or used with caution in patients with these conditions eg AV block greater than first degree or sinoatrial SA node dysfunction reactive airway disease concomitant use of verapamil or digoxin and Wolff-Parkinson-White WPW syndrome5
The DST requires a two-way stopcock which may not stock in some workplaces eg emergency medical services EMS and need the nursing staff to coordinate their actions administering the drug and flush simultaneously In the real world small hospitals had a transient shortage of medical equipment supply eg syringes The convenient method which combined adenosine and 15 mL of normal saline in one syringe was firstly proposed in the non-blind randomized prospective study between 1999 to 2001 and published the full original article in the Korean language since 2003 by Choi SC et al This trial demonstrated the success rate of the convenient method was higher than the standard method 857 vs 80 but its not statistically significant in addition the average of total administering doses and the complication of the convenient and standard method was not statistically different
Nearly two decades later Marc McDowell et al conducted a single-center prospective observational study with setting a 20 non-inferiority margin demonstrated that the successful conversion of SVT in the first dose 731 vs 407 and up to three doses 100 vs 704 in the single syringe technique SST and DST respectively And they didnt found any serious adverse effects eg dyspnea bradycardia or asystole Unfortunately superiority testing was not performed due to the limiting sample size
Therefore we hypothesized that the SST is non-inferior to the DST for terminating stable SVT by comparison a rate of successful conversion of SVT at the first 6 mg-dose of adenosine and the total average dosage of adenosine administered And we also aimed to compare the rate of side effects between both techniques of intravenous adenosine in those diagnosed with stable SVT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None