Clinical trial NCT02499796: Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation
Official title: Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Failure
Keywords: Invasive mechanical ventilation
Humidifying devices
Respiratory mechanics
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in muscle pressure-time product (PTPoes)
timeFrame: Baseline and 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Piero Ceriana, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.