Evidence map›Paper›PMID 38170571›Full record

ArticleJMIR research protocols2024

Impact of a Mobile App (LoAD Calc) on the Calculation of Maximum Safe Doses of Local Anesthetics: Protocol for a Randomized Controlled Trial.

Pietro Elias Fubini, Georges Louis Savoldelli, Tal Sara Beckmann, Caroline Flora Samer, Mélanie Suppan

Open access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Pietro Elias FubiniDivision of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.ORCID https://orcid.org/0000-0003-1371-6465
Georges Louis SavoldelliDivision of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.ORCID https://orcid.org/0000-0002-8968-6920
Tal Sara BeckmannDivision of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.ORCID https://orcid.org/0000-0002-1078-9338
Caroline Flora SamerClinical Pharmacology and Toxicology Division, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.ORCID https://orcid.org/0000-0001-8178-0616
Mélanie SuppanDivision of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.ORCID https://orcid.org/0000-0002-8807-9619
University Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLocal anesthetics (LAs) are regularly used to alleviate pain during medical or surgical procedures. Their use is generally considered safe, but exceeding the maximum recommended doses can lead to LA systemic toxicity, a rare but potentially lethal complication. Determining maximum safe doses is therefore mandatory before performing local anesthesia, but rules are often unclear and the factors affecting dose calculation are numerous. Mobile health apps have been shown to help clinical decision-making, but most currently available apps present significant limitations. The Local Anesthetics Dose Calculator (LoAD Calc) app was designed to overcome these limitations by taking all relevant parameters into account. Before deploying this app in a clinical setting, it should be tested to determine its effectiveness and whether clinicians would be willing to use it.

objectiveThe primary objective will be to evaluate the effectiveness of the LoAD Calc app through written simulated cases. The secondary objective will be to determine whether physicians find this app easier, faster, and safer than the methods they generally use.

methodsWe describe a parallel-group randomized controlled trial protocol. Anesthesiologists working at the Geneva University Hospitals will be invited to participate. Participants will be asked to compute the maximum dose of LA in 10 simulated clinical cases using 3 different LAs. The maximum safe dose will be determined manually using the same calculation rules that were used to develop LoAD Calc, without using the app itself. An overdose will be considered any dose higher than the correct dose, rounded to the superior integer, while an underdose will be defined as the optimal calculated dose minus 20%, rounded to the inferior integer. Randomization will be stratified according to current position (resident vs registrar). The participants allocated to the LoAD Calc (experimental) group will use the LoAD Calc app to compute the maximum safe LA doses. Those allocated to the control group will be asked to use the method they generally use. The primary outcome will be the overall overdose rate. Secondary outcomes will include the overdose rate according to ideal and actual body weight and to each specific LA, the overall underdose rate, and the time taken to complete these calculations. The app's usability will also be assessed.

resultsA sample size of 46 participants will be needed to detect a difference of 10% with a power of 90%. Thus, a target of 50 participants was set to allow for attrition and exclusion criteria. We expect recruitment to begin during the winter of 2023, data analysis in the spring of 2024, and results by the end of 2024.

conclusionsThis study should determine whether LoAD Calc, a mobile health app designed to compute maximum safe LA doses, is safer and more efficient than traditional LA calculation methods. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53679.

Indexed as

dose calculationdrug safetyinformation systems researchlocal anestheticslocal anesthetic systemic toxicitymobile health appstudy protocoltoxicity

Identifiers

PMID38170571
PMCPMC10794956
OpenAlexW4388861532

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.