Evidence map›Paper›PMID 30786030›Full record

Trial reportThe Laryngoscope2019

Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects.

Chathura B B Ratnayake, Renske Fles, I Bing Tan, Laura W J Baijens, Walmari Pilz, Cees A Meeuwis, Pauline H E Janssen-van Det, Rob van Son, Michiel W M Van den Brekel

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Laryngoscope, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. 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

9 authors at 4 institutions in 2 countries.

Chathura B B RatnayakeUniversity of Auckland, Auckland, New Zealand.ORCID 0000-0002-5188-9124
Renske FlesNetherlands Cancer Institute, Amsterdam, New Zealand.
I Bing TanNetherlands Cancer Institute, Amsterdam, New Zealand.
Laura W J BaijensDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Walmari PilzDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Cees A MeeuwisErasmus Medical Center, Rotterdam, The Netherlands.
Pauline H E Janssen-van DetErasmus Medical Center, Rotterdam, The Netherlands.
Rob van SonNetherlands Cancer Institute, Amsterdam, New Zealand.
Michiel W M Van den BrekelNetherlands Cancer Institute, Amsterdam, New Zealand.
Maastricht University Medical Centre · NLThe Netherlands Cancer Institute · NLErasmus MC · NLUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects.

methodsThis was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience.

resultsA significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6-24.0 hours], usual care [UC]: 21.5 hours [range: 6.0-24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty-six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study.

conclusionAn improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post-total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight. LEVEL OF EVIDENCE: 1b Laryngoscope, 129:2354-2360, 2019.

Indexed as

AgedAged, 80 and overAirway ManagementCross-Over StudiesFemaleHumansLaryngectomyLarynx, ArtificialMaleMiddle AgedNetherlandsPatient ComplianceProsthesis DesignTracheostomyTreatment OutcomeadhesivesHeat and moisture exchangerHME complianceProvox Lunaskin irritationtotal laryngectomytracheostoma

Identifiers

PMID30786030
PMCPMC6790615
OpenAlexW2916380888

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.