- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07833800
Table Height Effects on Spinal Success by Residents in Indonesia
Effects of Operating Table Height on Subarachnoid Block Success by Anesthesia Residents in Faculty of Medicine University of Indonesia
Operating table height influences operator comfort and performance during neuraxial anaesthesia, particularly when the patient is positioned sitting. This study aimed to analyse the effect of operating table height on the success rate and incidence of complications during spinal anesthesia, particularly done by trainees/residents.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients who met the inclusion criteria and did not meet any exclusion criteria were randomised by computer software into two groups according to operating table height - set with puncture site at the level of the operator's umbilicus or the operator's xiphoid process - with group allocation concealed in opaque envelopes. Operators were enrolled by consecutive sampling, consisting of anaesthesiology residents who met the eligibility criteria and were present in the operating theatre during the study period. The outcomes assessed included subarachnoid block success, procedural duration from needle insertion to free flow of cerebrospinal fluid, the need for needle redirection, the need for needle reinsertion, operator comfort, operator posture analysis, and minor complications such as paresthesia or vascular puncture
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Jakarta Special Capital Region
-
Jakarta Pusat, Jakarta Special Capital Region, Indonésie, 10430
- Universitas Indonesia
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- adult patients aged 18-65 years scheduled for elective surgery under neuraxial subarachnoid block anaesthesia
- classified as American Society of Anesthesiologists (ASA) physical status I-III
- operator had performed fewer than 39 prior subarachnoid blocks
Exclusion Criteria:
- body mass index >30 kg/m²
- contraindications to subarachnoid block
- patients' inability to be positioned sitting in accordance with the study protocol
- unwillingness to participate
- operator being unable to perform subarachnoid block according to protocol (injuries etc)
- table height being unable to be adjusted to the target level
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Umbilicus
Patients with table height set so that the puncture site is at operators' umbilicus level |
Table height set so that the puncture site is at operators' umbilicus or xyphoid process level |
|
Expérimental: Xyphoid process
Patients with table height set so that puncture site is at the operators' xyphoid process level |
Table height set so that the puncture site is at operators' umbilicus or xyphoid process level |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Procedure sucess
Délai: Periprocedural
|
Determined as free flowing cerebrospinal fluid in spinal needle hub with total procedure time less than 10 minutes, redirection less than 5 minutes, and reinsertion less than 3 times, without occurrence of paresthesia and bloody tao |
Periprocedural
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to sucess
Délai: Periprocedural
|
Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid |
Periprocedural
|
|
Redirection
Délai: Periprocedural
|
Numbers of needle redirection needed at the same puncture site |
Periprocedural
|
|
Reinsertion
Délai: Periprocedural
|
Numbers of spinal needle insertion (after fully pulled out from the skin) |
Periprocedural
|
|
Paresthesia
Délai: Periprocedural
|
Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure |
Periprocedural
|
|
Blood contamination
Délai: Periprocedural
|
Blood observed in spinal needle hub that went away after needle redirection |
Periprocedural
|
|
Bloody tap
Délai: Periprocedural
|
Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion |
Periprocedural
|
|
Subjective comfort assessment
Délai: Periprocedural
|
Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable" |
Periprocedural
|
|
Musculoskeletal complaints
Délai: Periprocedural
|
Perceived sensation of aches, pains, tiredness, or stiffness in certain body areas as measured by nordic body map. Minimum value is 0 and maximum value is 28. Higher scores mean worse outcome. |
Periprocedural
|
|
Body postures score
Délai: Periprocedural
|
Assessment of forced posture risk scoring using Rapid Entire Body Assessment. Minimum value is 1 and maximum value is 15. Higher scores mean worse outcome. |
Periprocedural
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rahendra Rahendra, MD, Universitas Indonesia
Publications et liens utiles
Publications générales
- ijerph19010595
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- 25-08-1204
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
All IPD collected during trial
Délai de partage IPD
Beginning 3 months and ending 3 years after the publication of results
Critères d'accès au partage IPD
De-identified participant data supporting the results reported in this article will be made available upon reasonable request to qualified researchers who provide a methodologically sound proposal via email. A data sharing agreement should be signed.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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