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Table Height Effects on Spinal Success by Residents in Indonesia

25. september 2026 opdateret af: Rahendra Rahendra, Universitas 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.

Studieoversigt

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Jakarta Special Capital Region
      • Jakarta Pusat, Jakarta Special Capital Region, Indonesien, 10430
        • Universitas Indonesia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedure sucess
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to sucess
Tidsramme: Periprocedural

Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid

Periprocedural
Redirection
Tidsramme: Periprocedural

Numbers of needle redirection needed at the same puncture site

Periprocedural
Reinsertion
Tidsramme: Periprocedural

Numbers of spinal needle insertion (after fully pulled out from the skin)

Periprocedural
Paresthesia
Tidsramme: Periprocedural

Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure

Periprocedural
Blood contamination
Tidsramme: Periprocedural

Blood observed in spinal needle hub that went away after needle redirection

Periprocedural
Bloody tap
Tidsramme: Periprocedural

Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion

Periprocedural
Subjective comfort assessment
Tidsramme: Periprocedural

Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable"

Periprocedural
Musculoskeletal complaints
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Rahendra Rahendra, MD, Universitas Indonesia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • ijerph19010595

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. november 2025

Primær færdiggørelse (Faktiske)

9. februar 2026

Studieafslutning (Faktiske)

9. februar 2026

Datoer for studieregistrering

Først indsendt

16. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 25-08-1204

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD collected during trial

IPD-delingstidsramme

Beginning 3 months and ending 3 years after the publication of results

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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