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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jakarta Special Capital Region
-
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
- Universitas Indonesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure sucess
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to sucess
Time Frame: Periprocedural
|
Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid |
Periprocedural
|
|
Redirection
Time Frame: Periprocedural
|
Numbers of needle redirection needed at the same puncture site |
Periprocedural
|
|
Reinsertion
Time Frame: Periprocedural
|
Numbers of spinal needle insertion (after fully pulled out from the skin) |
Periprocedural
|
|
Paresthesia
Time Frame: Periprocedural
|
Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure |
Periprocedural
|
|
Blood contamination
Time Frame: Periprocedural
|
Blood observed in spinal needle hub that went away after needle redirection |
Periprocedural
|
|
Bloody tap
Time Frame: Periprocedural
|
Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion |
Periprocedural
|
|
Subjective comfort assessment
Time Frame: Periprocedural
|
Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable" |
Periprocedural
|
|
Musculoskeletal complaints
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rahendra Rahendra, MD, Universitas Indonesia
Publications and helpful links
General Publications
- ijerph19010595
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25-08-1204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
All IPD collected during trial
IPD Sharing Time Frame
Beginning 3 months and ending 3 years after the publication of results
IPD Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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