Evidence map›Paper›PMID 34446500›Full record

ArticleBMJ open2021

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.

Yaseen M Arabi, Haytham Tlayjeh, Sara Aldekhyl, Hasan M Al-Dorzi, Sheryl Ann Abdukahil, Mohammad Khulaif Al Harbi, Husain Al Haji, Mohammed Al Mutairi, Omar Al Zumai, Eman Al Qasim and 25 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04477668 (Helmet Non-Invasive Ventilation for COVID-19 Patients), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT04477668 nacompletednot on this map

Helmet Non-Invasive Ventilation for COVID-19 Patients

TypeinterventionalSponsorKing Abdullah International Medical Research CenterRan2021 to 2022Enrolled322ConditionsCOVID-19, Acute Hypoxemic Respiratory FailureArmsHelmet non-invasive ventilation
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. 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

35 authors at 14 institutions in 3 countries.

Yaseen M ArabiIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia yaseenarabi@yahoo.com.ORCID 0000-0001-5735-6241
Haytham TlayjehIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Sara AldekhylIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Hasan M Al-DorziIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Sheryl Ann AbdukahilIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Mohammad Khulaif Al HarbiCollege of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Husain Al HajiRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Mohammed Al MutairiRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Omar Al ZumaiRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Eman Al QasimIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Wedyan Al WehaibiIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Saad Al QahtaniIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Fahad Al-HameedIntensive Care Department, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia.
Jamal ChalabiIntensive Care Department, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia.
Mohammed AlshahraniDepartments of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia.
Talal AlbrahimDepartment of Critical Care, Imam Abdulrahman Bin Faisal University, King Fahad Hospital of the University, Al Khobar, Saudi Arabia.
Abdulrahman AlharthyIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Ahmed MadyIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Abdulhadi Bin EshaqIntensive Care Department, King Khalid Hospital Najran, Najran, Saudi Arabia.
Ali A Al BshabsheCollege of Medicine, King Khalid University, Abha, Saudi Arabia.ORCID 0000-0003-0974-7226
Zohair Al AseriDepartments of Emergency Medicine and Critical Care, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Zainab Al DuhailibAdult Critical Care Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Ayman KharabaPulmonary and Critical Care Departments, King Fahad Hospital Madinah, Madinah, Saudi Arabia.
Rakan AlqahtaniDepartment of Critical Care Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Adnan Al GhamdiDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Ali AltalagDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Khalid AlghamdiIntensive Care Department, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi Arabia.
Mohammed AlmaaniDepartment of Pulmonary and Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
Haifa AlgethamyDepartment of Anesthesia and Critical Care, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Ahmad Al AqeilyRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Faisal Al BaseetRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Hashem Al SamannoudiRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Mohammed Al ObaidiRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Yassin T IsmaielRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Abdulrahman A Al-FaresDepartment of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Kuwait.
King Saud bin Abdulaziz University for Health Sciences · SANational Guard Health Affairs · SAKing Fahd Hospital of the University · SAKing Faisal Specialist Hospital & Research Centre · SAKing Saud University · SARiyadh Armed Forces Hospital · SAAmiri Hospital · KWAsir Central Hospital · SAKing Abdulaziz University · SAKing Fahad Hospital Jeddah · SAKing Fahd Medical City · SAKing Khaled Hospital · SAKing Saud Medical City · SATanta University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNon-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality. METHODS AND ANALYSIS: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. ETHICS AND DISSEMINATION: Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings. TRIAL REGISTRATION NUMBER: NCT04477668.

Indexed as

COVID-19Noninvasive VentilationRespiratory InsufficiencyHead Protective DevicesHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSARS-CoV-2adult intensive & critical careCOVID-19respiratory medicine (see thoracic medicine)

Identifiers

PMID34446500
PMCPMC8392742
OpenAlexW3195926780

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.