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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date February 14, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Change in muscle pressure-time product (PTPoes) [ Time Frame: Baseline and 60 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation
Official Title  ICMJE Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Chronic Respiratory Failure
Intervention  ICMJE
  • Device: Hygrovent Gold
  • Device: Heated and moisture exchanger (HME)
  • Device: Heated humidifier (HH)
Study Arms  ICMJE 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
Interventions:
  • Device: Hygrovent Gold
  • Device: Heated and moisture exchanger (HME)
  • Device: Heated humidifier (HH)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499796
Other Study ID Numbers  ICMJE 981
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Annia Schreiber, Fondazione Salvatore Maugeri
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fondazione Salvatore Maugeri
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Piero Ceriana, MD Fondazione Salvatore Maugeri
PRS Account Fondazione Salvatore Maugeri
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP