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OpenTrials
Completed

NCT Number: NCT01645358

Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.

In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.

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Key information

Conditions

Hypercapnic Respiratory Failure Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sant'Orsola Malpighi, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pH < 7,35 and PaCO2 > 45 mmHg
  • respiratory rate > 20 b/min

Exclusion criteria

  • hypoxic respiratory failure
  • coma
  • inability to stand NIV
  • lack of informed consent

Treatment and study plan

Helmet (Starmed)

Device

The helmet is a kind of interface similar to a hood to deliver NIV

Other names: Starmed Helmet

Total Face mask (Respironics)

Device

The total face mask is the "classical" interface for NIV delivery

Other names: Respironics Performax or similar

Primary outcomes

  1. Arterial Blood gases

    Time frame: at 1 hour after the start of NIV

Secondary outcomes

  1. Arterial Blood Gases

    Time frame: Once a day at 8 am until discharge

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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