Helmet Ventilation in Acute Hypercapnic Respiratory Failure

NCT01645358 | Completed Phase 4

• 1 other identifier: 1222
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease

Keywords

COPD; NIV; Acute Hypercapnic Respiratory Failure; COPD patients with hypercapnic respiratory failure

Outcome Measures

Primary Outcomes (1)

• Arterial Blood gases

  at 1 hour after the start of NIV

Secondary Outcomes (1)

• Arterial Blood Gases

  Once a day at 8 am until discharge

Study Arms (2)

Helmet to deliver NIV

EXPERIMENTAL

Device: Helmet (Starmed)

Total Face to deliver NIV

ACTIVE COMPARATOR

Device: Total Face mask (Respironics)

Interventions

Helmet (Starmed) DEVICE

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

Also known as: Starmed Helmet

Helmet to deliver NIV

Total Face mask (Respironics) DEVICE

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

Also known as: Respironics Performax or similar

Total Face to deliver NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Sant'Orsola malpighi Hospital

Bologna, 40185, Italy

Location

Sant'Orsola Malpighi

Bologna, 40185, Italy

Location

Related Publications (1)

• Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.

  PMID: 25504992 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Respiratory and Critical care

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

IT (2)