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

Primary Purpose

Chronic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hygrovent Gold
Heated and moisture exchanger (HME)
Heated humidifier (HH)
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Respiratory Failure focused on measuring Invasive mechanical ventilation, Humidifying devices, Respiratory mechanics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Salvatore Maugeri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in muscle pressure-time product (PTPoes)

Secondary Outcome Measures

Full Information

First Posted
July 8, 2015
Last Updated
February 13, 2018
Sponsor
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT02499796
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
Keywords
Invasive mechanical ventilation, Humidifying devices, Respiratory mechanics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Hygrovent Gold
Intervention Type
Device
Intervention Name(s)
Heated and moisture exchanger (HME)
Intervention Type
Device
Intervention Name(s)
Heated humidifier (HH)
Primary Outcome Measure Information:
Title
Change in muscle pressure-time product (PTPoes)
Time Frame
Baseline and 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piero Ceriana, MD
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12415444
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.
Results Reference
background
PubMed Identifier
12415445
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.
Results Reference
background
PubMed Identifier
31270176
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.
Results Reference
derived

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

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