Evidence map›Paper›PMID 35346339›Full record

ArticleTrials2022

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial.

Melissa Earwaker, Sofia Villar, Julia Fox-Rushby, Melissa Duckworth, Sarah Dawson, Jo Steele, Yi-da Chiu, Edward Litton, Gudrun Kunst, Gavin Murphy and 5 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
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

15 authors at 6 institutions in 2 countries.

Melissa EarwakerPapworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, UK. melissa.earwaker@nhs.net.ORCID http://orcid.org/0000-0002-5448-2354
Sofia VillarMRC Biostatistics Unit, Cambridge University, Cambridge, UK.
Julia Fox-RushbyKing's College London, London, UK.
Melissa DuckworthPapworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, UK.
Sarah DawsonMRC Biostatistics Unit, Cambridge University, Cambridge, UK.
Jo SteelePapworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, UK.
Yi-da ChiuPapworth Trials Unit, Royal Papworth Hospital, Cambridge, UK.
Edward LittonIntensive Care Unit, Fiona Stanley Hospital, Perth, Western Australia, Australia.
Gudrun KunstKing's College London, London, UK.
Gavin MurphyUniversity of Leicester, Leicester, UK.
Guillermo MartinezPapworth Trials Unit, Royal Papworth Hospital, Cambridge, UK.
Vasileios ZochiosUniversity Hospitals Birmingham, Birmingham, UK.
Val BrownPapworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, UK.
Geoff BrownPapworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, UK.
Andrew KleinDepartment of Anaesthesia, Royal Papworth Hospital, Cambridge, UK.
Papworth Hospital · GBKing's College London · GBUniversity of Cambridge · GBFiona Stanley Hospital · AUNIHR Surgical Reconstruction and Microbiology Research Centre · GBUniversity of Leicester · GB

Funding

British Heart Foundation CH/12/1/29419British Heart Foundation RG/17/9/32812Department of Health NIHR128351national institute of health research 128351
6 · The paper itself

Abstract

backgroundHigh-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients.

methodsThis is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. DISCUSSION: Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking.

trial registrationThe study has been registered with ISRCTN ( ISRCTN14092678 , 13/05/2020) Clinicaltrials.gov Registration Pending.

Indexed as

Cardiac Surgical ProceduresHumansLungMulticenter Studies as TopicOxygen Inhalation TherapyPilot ProjectsPostoperative ComplicationsRandomized Controlled Trials as TopicAdaptive designCardiothoracic surgeryHigh-flow nasal therapyPost-operative pulmonary complications

Identifiers

PMID35346339
PMCPMC8959074
OpenAlexW4220899796

What OpenQuestion holds

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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.