Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation

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ClinicalTrials.gov Identifier: NCT02499796

Recruitment Status : Completed

First Posted : July 16, 2015

Last Update Posted : February 14, 2018

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Sponsor:

Information provided by (Responsible Party):

Annia Schreiber, Fondazione Salvatore Maugeri

Study Description

Brief Summary:

This study compares the short-term effects of a new humidification system (Hygrovent Gold) and two other humidification devices (heated and moisture exchanger and heated humidifier) on respiratory pattern and work of breathing, during invasive ventilation.

Condition or disease	Intervention/treatment	Phase
Chronic Respiratory Failure	Device: Hygrovent Gold Device: Heated and moisture exchanger (HME) Device: Heated humidifier (HH)	Not Applicable

Detailed Description:

Three humidifying devices are commonly and indifferently used during mechanical ventilation, but their impact on respiratory mechanics and, eventually, mechanical ventilation efficacy, particularly in patients highly dependent from mechanical ventilation, are not superimposable.

It has already been described that heated and moisture exchangers (HME), increasing dead space, can negatively affect ventilatory function and gas exchange, in comparison to heated humidifiers (HH).

The Hygrovent Gold, mainly because of its position between the tracheostomy and the Y-piece of the ventilatory circuit and its structure, may lead to analogous or even worse effects, determining and increase in inspiratory resistances and dead space and consequently an increase in the work of breathing.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	15 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation
Study Start Date :	April 2015
Actual Primary Completion Date :	September 2015
Actual Study Completion Date :	September 2015

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Arm Every patient receives 20 minutes of invasive mechanical ventilation with each of the three humidification systems in random sequence: Heated and moisture exchanger (HME) Heated humidifier (HH) Hygrovent Gold	Device: Hygrovent Gold Device: Heated and moisture exchanger (HME) Device: Heated humidifier (HH)

Outcome Measures

Primary Outcome Measures :

Change in muscle pressure-time product (PTPoes) [ Time Frame: Baseline and 60 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic hypercapnic respiratory failure (PaCO2 of 45 mmHg or more)
Long-term mechanical ventilation via tracheostomy
Clinical stability

Exclusion Criteria:

Non collaborative subjects
Acute respiratory failure
Haemodynamic instability
Encephalopathy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499796

Locations

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Italy
Fondazione Salvatore Maugeri
Pavia, Italy, 27100

Sponsors and Collaborators

Fondazione Salvatore Maugeri

Investigators

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Study Chair:	Piero Ceriana, MD	Fondazione Salvatore Maugeri

More Information

Publications:

Lellouche F, Maggiore SM, Deye N, Taille S, Pigeot J, Harf A, Brochard L. Effect of the humidification device on the work of breathing during noninvasive ventilation. Intensive Care Med. 2002 Nov;28(11):1582-9. doi: 10.1007/s00134-002-1518-9. Epub 2002 Oct 10.

Jaber S, Chanques G, Matecki S, Ramonatxo M, Souche B, Perrigault PF, Eledjam JJ. Comparison of the effects of heat and moisture exchangers and heated humidifiers on ventilation and gas exchange during non-invasive ventilation. Intensive Care Med. 2002 Nov;28(11):1590-4. doi: 10.1007/s00134-002-1441-0. Epub 2002 Sep 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schreiber AF, Ceriana P, Ambrosino N, Piran M, Malovini A, Carlucci A. Short-Term Effects of an Active Heat-and-Moisture Exchanger During Invasive Ventilation. Respir Care. 2019 Oct;64(10):1215-1221. doi: 10.4187/respcare.06799. Epub 2019 Jul 3.

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Responsible Party:	Annia Schreiber, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT02499796
Other Study ID Numbers:	981
First Posted:	July 16, 2015 Key Record Dates
Last Update Posted:	February 14, 2018
Last Verified:	February 2018

Keywords provided by Annia Schreiber, Fondazione Salvatore Maugeri:


Invasive mechanical ventilation Humidifying devices Respiratory mechanics

Additional relevant MeSH terms:

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Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

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