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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Jakarta Special Capital Region
-
Jakarta Pusat, Jakarta Special Capital Region, Indonesië, 10430
- Universitas Indonesia
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Procedure sucess
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to sucess
Tijdsspanne: Periprocedural
|
Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid |
Periprocedural
|
|
Redirection
Tijdsspanne: Periprocedural
|
Numbers of needle redirection needed at the same puncture site |
Periprocedural
|
|
Reinsertion
Tijdsspanne: Periprocedural
|
Numbers of spinal needle insertion (after fully pulled out from the skin) |
Periprocedural
|
|
Paresthesia
Tijdsspanne: Periprocedural
|
Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure |
Periprocedural
|
|
Blood contamination
Tijdsspanne: Periprocedural
|
Blood observed in spinal needle hub that went away after needle redirection |
Periprocedural
|
|
Bloody tap
Tijdsspanne: Periprocedural
|
Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion |
Periprocedural
|
|
Subjective comfort assessment
Tijdsspanne: Periprocedural
|
Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable" |
Periprocedural
|
|
Musculoskeletal complaints
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rahendra Rahendra, MD, Universitas Indonesia
Publicaties en nuttige links
Algemene publicaties
- ijerph19010595
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 25-08-1204
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
All IPD collected during trial
IPD-tijdsbestek voor delen
Beginning 3 months and ending 3 years after the publication of results
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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