- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07691554
Comparison of Short-Axis and Long-Axis Internal Jugular Vein Cannulation for First-Pass Success
Comparison Between Short Axis and Long Axis For Cannulation Of Internal Jugular Vein in Terms Of First Pass Success
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This randomized controlled trial aims to compare the effectiveness of short-axis and long-axis ultrasound-guided approaches for cannulation of the internal jugular vein (IJV) in terms of first-pass success. Central venous catheterization is a commonly performed procedure for invasive monitoring and administration of medications and fluids. Ultrasound guidance has improved the safety and success of IJV cannulation compared with traditional landmark-based techniques; however, uncertainty remains regarding the optimal ultrasound imaging approach.
A total of 60 eligible patients undergoing IJV cannulation will be enrolled and randomly allocated into two equal groups. Participants in Group A will undergo ultrasound-guided IJV cannulation using the short-axis approach, while participants in Group B will undergo cannulation using the long-axis approach. All procedures will be performed by the researcher under direct supervision using standardized ultrasound-guided techniques.
The primary objective is to compare the frequency of first-pass success between the two approaches. First-pass success is defined as successful IJV cannulation with a single skin puncture and without needle redirection. Baseline demographic and clinical characteristics will be recorded before the procedure. The findings of this study may help identify the preferred ultrasound-guided technique for maximizing first-pass success during IJV cannulation and potentially reducing procedure-related complications associated with multiple cannulation attempts.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Waleed Noor, MBBS FCPS
- Numéro de téléphone: +923154960902
- E-mail: mrwaleed2394@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Shahida Khawaja, MBBS FCPS
- Numéro de téléphone: +92 300 8462091
- E-mail: khawaja.shahida@gmail.com
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- National Hospital and Medical Center
-
Contact:
- National Hospital and Medical Center
- Numéro de téléphone: +9242 111 17 18 19
- E-mail: info@nationalhospital.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 25-70 years.
- Either male or female gender.
- Undergoing cannulation of IJV.
Exclusion Criteria:
- Patients who will be on hemodialysis therapy through double lumen catheter in IJV, assessed by reviewing previous medical records.
- Patients who will have history of previous insertion of IJV line, assessed by reviewing previous medical records.
- Patients with history of neck surgery, assessed by reviewing previous medical records.
- Uncooperative patient.
- Platelet count < 50,000/mm3.
- International normalized ration 3 times upper normal limit (1.1).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group A (Short-Axis Approach)
In this approach, IJV will be visualized by placing the transducer in a transverse orientation on the patient neck at the level of the cricoid cartilage.
The needle will be inserted at 60° to the vertical and will be advanced toward the vein employing gentle aspiration on the attached syringe.
Entry to the vein will be confirmed by visualizing indentation of the anterior wall of the vein followed by blood in the syringe and by visualizing the tip of the needle inside the vein.
Guide wire will be passed followed by dilator insertion and finally central vein line.
|
Internal jugular vein cannulation performed under ultrasound guidance using the short-axis approach.
The transducer is placed in a transverse orientation at the level of the cricoid cartilage, allowing visualization of the internal jugular vein and carotid artery during needle insertion.
|
|
Comparateur actif: Group B (Long-Axis Approach)
In this approach, the probe will be centered on the IJV and rotated through 90° in a clockwise direction resulting in long axis image of the vein.
The needle insertion point will be directly beneath the most proximal end of the ultrasound probe.
The needle will be inserted at 30° to the vertical and will be advanced toward the vein employing gentle aspiration.
Entry to the vein will be confirmed by visualizing needle entry into the vein followed by aspiration of blood in the syringe.
Guide wire will be inserted followed by dilator insertion and finally central vein line.
|
Internal jugular vein cannulation performed under ultrasound guidance using the long-axis approach.
The transducer is rotated to obtain a longitudinal view of the internal jugular vein, allowing continuous visualization of the needle during vessel cannulation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
First-Pass Success Rate of Ultrasound-Guided Internal Jugular Vein Cannulation
Délai: Assessed during the cannulation procedure (within 5 minutes of initiation of cannulation).
|
First-pass success rate of ultrasound-guided internal jugular vein cannulation, defined as successful venous cannulation with a single skin puncture and needle pass.
|
Assessed during the cannulation procedure (within 5 minutes of initiation of cannulation).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Cannulation Success Rate
Délai: Assessed during the procedure (within 15 minutes).
|
Total cannulation success rate, defined as successful placement of the internal jugular venous catheter.
|
Assessed during the procedure (within 15 minutes).
|
|
Number of Needle Passes Required for Successful Cannulation
Délai: Recorded during the procedure.
|
Total number of needle insertion attempts required to achieve successful ultrasound-guided internal jugular vein cannulation.
|
Recorded during the procedure.
|
|
Incidence of Hematoma Formation at the Cannulation Site
Délai: Assessed immediately after the procedure and within 24 hours.
|
Occurrence of hematoma at the internal jugular vein cannulation site following ultrasound-guided catheter insertion.
|
Assessed immediately after the procedure and within 24 hours.
|
|
Incidence of Posterior Vessel Wall Puncture
Délai: Assessed during the procedure.
|
Occurrence of unintended puncture of the posterior wall of the internal jugular vein during ultrasound-guided cannulation.
|
Assessed during the procedure.
|
|
Incidence of Pneumothorax Following Cannulation
Délai: Assessed within 24 hours following cannulation.
|
Occurrence of pneumothorax associated with ultrasound-guided internal jugular vein cannulation.
|
Assessed within 24 hours following cannulation.
|
|
Overall Procedure-Related Complications
Délai: Assessed during the procedure and up to 24 hours after cannulation.
|
Frequency of procedure-related adverse events, including hematoma, posterior vessel wall puncture, pneumothorax, or other complications occurring during or after ultrasound-guided internal jugular vein cannulation.
|
Assessed during the procedure and up to 24 hours after cannulation.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Shahida Khawaja, MBBS, FCPS, National Hospital and Medical Center
Publications et liens utiles
Publications générales
- Shrestha GS, Gurung A, Koirala S. Comparison between long- and short-axis techniques for ultrasound-guided cannulation of internal jugular vein. Ann Card Anaesth. 2016 Apr-Jun;19(2):288-92. doi: 10.4103/0971-9784.179629.
- Rath A, Mishra SB, Pati B, Dhar SK, Ipsita S, Samal S, Azim A. Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial. Am J Emerg Med. 2020 Apr;38(4):731-734. doi: 10.1016/j.ajem.2019.06.010. Epub 2019 Jun 14.
- Tolson OW. Should central venous pressure be used to guide critical care management? Br J Hosp Med (Lond). 2022 Oct 2;83(10):1-3. doi: 10.12968/hmed.2022.0167. Epub 2022 Oct 11.
Liens utiles
- Should central venous pressure be used to guide critical care management?
- Central venous catheterization in cancer patients with severe thrombocytopenia: Ultrasound-guide improves safety avoiding prophylactic platelet transfusion
- Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial
- Comparing 1st Pass Success Rate and Number of Attempts for Internal Jugular Vein Cannulation by USG Guided Approach: Short Axis versus Long Axis Technique
- A Comparative Study of Internal Jugular Vein Cannulation under Ultrasound Guidance Using Short Axis or Long Axis View Approach
- Comparison between long- and short-axis techniques for ultrasound-guided cannulation of internal jugular vein
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 06-10-2023
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .