Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure

Respiratory Failure With Hypoxia Clinical Trial

— HENIVOTpilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502576
• Other study ID #: 4443
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure.

As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established.

The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 1, 2022
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30

Exclusion Criteria:

Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face

Related Conditions & MeSH terms

• Hypoxia
• Respiratory Failure With Hypoxia
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive respiratory support
In both arms, the treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit

Locations

Country	Name	City	State
Italy	Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna	Bologna
Italy	SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara	Chieti
Italy	Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara	Ferrara
Italy	Infermi Hospital	Rimini
Italy	Fondazione Policlinico Universitaro A. Gemelli IRCCS	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva, Università degli studi di Chieti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory-support free days within 28 days from randomization	The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)	28 days
Secondary	Endotracheal intubation	The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee	28 days
Secondary	Invasive ventilation-free days within 28 days from randomization	The number of days in which patients did not receive invasive mechanical ventilation	28 days
Secondary	Invasive ventilation-free days within 60 days from randomization	The number of days in which patients did not receive invasive mechanical ventilation	60 days
Secondary	Oxygenation	The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge	28 days
Secondary	Carbon dioxide	PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge	28 days
Secondary	Dyspnea	Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge	28 days
Secondary	Respiratory rate	Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge	28 days
Secondary	In-intensive care unit mortality	Clinical outcome (dead/alive) at intensive care unit discharge	90 days
Secondary	In-hospital mortality	Clinical outcome (dead/alive) at hospital discharge	90 days
Secondary	90-day mortality	Clinical outcome (dead/alive) at 90 days after randomization	90 days
Secondary	Quality of life after recovery	Quality of life in survivors, assessed by Short Form-36 questionnaire	1 year