Evidence map›Paper›PMID 39613437›Full record

ArticleBMJ open2024

Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study).

Jerome Stirnemann, Jacques Serratrice, Tamara Mann, Pierre Louge, Combescure Christophe, Kaveh Samii, Rodrigue Pignel, Thomas Agoritsas, Marc Ansari, Giovanna Cannas and 17 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04978116 (Low-dose CT Compared to Lung Ultrasonography vs Standard of Care for the Diagnosis of Pneumonia in the Elderly), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT04978116 nacompletednot on this map

Low-dose CT Compared to Lung Ultrasonography vs Standard of Care for the Diagnosis of Pneumonia in the Elderly: a Multicentre Randomized Controlled Study

TypeinterventionalSponsorUniversity Hospital, GenevaRan2021 to 2025Enrolled473ConditionsPneumonia, Elderly InfectionArmsChest X-Ray (CXR), Low-dose CT scan (LDCT), Lung ultrasonography (LUS)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

27 authors.

Jerome StirnemannDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland Jerome.stirnemann@hcuge.ch.ORCID http://orcid.org/0000-0001-9964-4452
Jacques SerratriceDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Tamara MannDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Pierre LougeSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Combescure ChristopheDiagnostic of Health and Community Medicine, Geneva University Hospitals, Geneva, Switzerland.
Kaveh SamiiDivision of Haematology, Geneva University Hospitals, Geneva, Switzerland.
Rodrigue PignelSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Thomas AgoritsasDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Marc AnsariCANSEARCH Research Platform in Paediatric Oncology and Haematology of the University of Geneva, University of Geneva, Geneva, Switzerland.
Giovanna CannasSickle-Cell Disease Reference Center, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France.
Yves ChalandonHematology Department, Geneva University Hospitals, Geneva, Switzerland.
Laurent CimasoniDivision of Paediatric Oncology and Haematology, Geneva University Hospitals, Geneva, Switzerland.
Pierre CougoulSickle-cell Reference Center, Institut Universitaire du Cancer de Toulouse Oncopole CHU Toulouse, Toulouse, Occitanie, France.
Benoit DesgrazSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Alain GervaixDepartment of Women-Children-Teenagers, Geneva University Hospitalse, Geneva, Switzerland.
Olivier GrosgurinDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Thierry JoffreHyperbaric Center, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France.
Claude LaeSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Marie-Anne MagnanSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Etienne MenagerSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Annie Momo BonaEmergency Department, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, Occitanie, France.
Marc-Alain PanchardSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Michel PellegriniSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.
Jean-Luc RenyDepartment of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Beatrice RiuHyperbaric Center, Institut Universitaire du Cancer de Toulouse Oncopole CHU Toulouse, Toulouse, Occitanie, France.
Cyril SahyounDepartment of Women-Children-Teenagers, Geneva University Hospitals Children's Hospital, Geneva, Switzerland.
Sylvain BoetSubaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSickle cell disease (SCD) is one of the most common genetic diseases in the world, annually affecting approximately 310 000 births and causing >100 000 deaths. Vaso-occlusive crisis (VOC) is the most frequent complication of SCD, leading to bone pain, thoracic pain (acute chest syndrome) and/or abdominal spasms. It is the main cause of mortality in patients with SCD, reducing life expectancy. Hyperbaric oxygen therapy (HBOT) is a safe and well-established method of increasing tissue oxygen delivery immediately by up to 10-fold to 20-fold. In the context of VOC, HBOT has the potential to limit sickling. A previous pilot study of nine patients showed the safety and potential benefits of HBOT on VOC-induced pain. Our study aimed to assess the clinical safety and effectiveness of HBOT for treating VOC, its biological mechanisms of actions and its cost-effectiveness. METHODS AND ANALYSIS: This is a multicentric, triple-blinded, randomised controlled trial. Patients aged 8 years or above with a diagnosed major form of SCD, presenting at one of the participating centres' emergency departments (EDs) with a VOC requiring level 3 analgesia (according to WHO definition), will be eligible. Exclusion criteria are pregnancy, mechanical ventilation, previous history of stroke or prior transcranial Doppler ultrasound anomaly, contraindication to HBOT and the need for above 2 L/min of oxygen. All patients will receive the usual care for VOCs, including hydration, analgesics, normobaric oxygen therapy and when medically indicated, antibiotic therapy and/or transfusions. Within 24 hours of their arrival in the ED (or longer in specific cases), and after obtaining informed consent, patients will be randomised into the HBOT intervention group (2.0 atmosphere absolute (ATA), 90 min, FIO ETHICS AND DISSEMINATION: Ethical approval CER Geneva 2019-01707 (last submission V.5.1, 06.15.2023). The results of the studies will be disseminated by several media, including publications in peer-reviewed international medical journals, and presentations at national and/or international conferences. TRIAL REGISTRATION NUMBER: NCT04978116.

Indexed as

Anemia, Sickle CellHyperbaric OxygenationAdolescentAdultChildDouble-Blind MethodFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicYoung AdultAnaemiaEmergency Service, HospitalINTERNAL MEDICINE

Identifiers

PMID39613437
PMCPMC11605825

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.