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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Jakarta Special Capital Region
-
Jakarta Pusat, Jakarta Special Capital Region, Indonesien, 10430
- Universitas Indonesia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procedure sucess
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to sucess
Tidsram: Periprocedural
|
Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid |
Periprocedural
|
|
Redirection
Tidsram: Periprocedural
|
Numbers of needle redirection needed at the same puncture site |
Periprocedural
|
|
Reinsertion
Tidsram: Periprocedural
|
Numbers of spinal needle insertion (after fully pulled out from the skin) |
Periprocedural
|
|
Paresthesia
Tidsram: Periprocedural
|
Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure |
Periprocedural
|
|
Blood contamination
Tidsram: Periprocedural
|
Blood observed in spinal needle hub that went away after needle redirection |
Periprocedural
|
|
Bloody tap
Tidsram: Periprocedural
|
Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion |
Periprocedural
|
|
Subjective comfort assessment
Tidsram: Periprocedural
|
Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable" |
Periprocedural
|
|
Musculoskeletal complaints
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Rahendra Rahendra, MD, Universitas Indonesia
Publikationer och användbara länkar
Allmänna publikationer
- ijerph19010595
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 25-08-1204
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
All IPD collected during trial
Tidsram för IPD-delning
Beginning 3 months and ending 3 years after the publication of results
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .