Evidence map›Paper›PMID 37208787›Full record

ArticleJournal of intensive care2023

Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial.

Teresa Michi, Chiara Mattana, Luca S Menga, Maria Grazia Bocci, Melania Cesarano, Tommaso Rosà, Maria Rosaria Gualano, Jonathan Montomoli, Savino Spadaro, Matteo Tosato and 15 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of intensive care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04502576 (Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT04502576 nacompletednot on this map

Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2020 to 2022Enrolled110ConditionsRespiratory Failure With HypoxiaArmsNoninvasive respiratory support
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. 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

25 authors at 7 institutions in 3 countries.

Teresa MichiDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Chiara MattanaDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Luca S MengaDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Maria Grazia BocciDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Melania CesaranoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Tommaso RosàDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Maria Rosaria GualanoDepartment of Hygiene and Public Health, UniCamillus University, Rome, Italy.
Jonathan MontomoliDepartment of Anaesthesia and Intensive Care, Infermi Hospital, Rimini, Italy.
Savino SpadaroDepartment of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.
Matteo TosatoGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Elisabetta RotaGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Francesco LandiGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Salvatore L CutuliDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Eloisa S TanzarellaDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Gabriele PintaudiDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Edoardo PiervincenziDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Giuseppe BelloDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Tommaso TonettiDepartment of Medical and Surgical Sciences, Anesthesia and Intensive Care Medicine, Alma Mater Studiorum, Policlinico Di Sant'Orsola, Università Di Bologna, Bologna, Italy.
Paola RucciDepartment of Biomedical and Neuromotor Science, Alma Mater Studiorum-Università Di Bologna, Bologna, Italy.
Gennaro De PascaleDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Salvatore M MaggioreDepartment of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata Hospital, Chieti, Italy.
Domenico Luca GriecoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy. dlgrieco@outlook.it.ORCID http://orcid.org/0000-0002-4557-6308
Giorgio ContiDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Massimo AntonelliDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.
Gemelli COVID-ICU study group
Università Cattolica del Sacro Cuore · ITCorvid Technologies (United States) · USAgostino Gemelli University Polyclinic · ITUniversity of Ferrara · ITOspedale Infermi di Rimini · ITOspedale SS. Annunziata · ITUniversity of Bologna · IT

Funding

SIAARTI 2017 MSD award
6 · The paper itself

Abstract

backgroundLong-term outcomes of patients treated with helmet noninvasive ventilation (NIV) are unknown: safety concerns regarding the risk of patient self-inflicted lung injury and delayed intubation exist when NIV is applied in hypoxemic patients. We assessed the 6-month outcome of patients who received helmet NIV or high-flow nasal oxygen for COVID-19 hypoxemic respiratory failure.

methodsIn this prespecified analysis of a randomized trial of helmet NIV versus high-flow nasal oxygen (HENIVOT), clinical status, physical performance (6-min-walking-test and 30-s chair stand test), respiratory function and quality of life (EuroQoL five dimensions five levels questionnaire, EuroQoL VAS, SF36 and Post-Traumatic Stress Disorder Checklist for the DSM) were evaluated 6 months after the enrollment.

resultsAmong 80 patients who were alive, 71 (89%) completed the follow-up: 35 had received helmet NIV, 36 high-flow oxygen. There was no inter-group difference in any item concerning vital signs (N = 4), physical performance (N = 18), respiratory function (N = 27), quality of life (N = 21) and laboratory tests (N = 15). Arthralgia was significantly lower in the helmet group (16% vs. 55%, p = 0.002). Fifty-two percent of patients in helmet group vs. 63% of patients in high-flow group had diffusing capacity of the lungs for carbon monoxide < 80% of predicted (p = 0.44); 13% vs. 22% had forced vital capacity < 80% of predicted (p = 0.51). Both groups reported similar degree of pain (p = 0.81) and anxiety (p = 0.81) at the EQ-5D-5L test; the EQ-VAS score was similar in the two groups (p = 0.27). Compared to patients who successfully avoided invasive mechanical ventilation (54/71, 76%), intubated patients (17/71, 24%) had significantly worse pulmonary function (median diffusing capacity of the lungs for carbon monoxide 66% [Interquartile range: 47-77] of predicted vs. 80% [71-88], p = 0.005) and decreased quality of life (EQ-VAS: 70 [53-70] vs. 80 [70-83], p = 0.01).

conclusionsIn patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome at 6 months. The need for invasive mechanical ventilation was associated with worse outcomes. These data indicate that helmet NIV, as applied in the HENIVOT trial, can be safely used in hypoxemic patients. Trial registration Registered on clinicaltrials.gov NCT04502576 on August 6, 2020.

Indexed as

Acute respiratory failureCOVID-19HelmetHigh-flow nasal oxygenNoninvasive ventilationPatient self-inflicted lung injury (P-SILI)

Identifiers

PMID37208787
PMCPMC10195662
OpenAlexW4377098014

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.