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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
Sponsor:
Information provided by (Responsible Party):
Annia Schreiber, Fondazione Salvatore Maugeri

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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

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)



Primary Outcome Measures :
  1. Change in muscle pressure-time product (PTPoes) [ Time Frame: Baseline and 60 minutes ]


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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

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annia Schreiber, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT02499796     History of Changes
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