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OpenTrials
Completed

NCT Number: NCT02499796

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Salvatore Maugeri

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hygrovent Gold

Device

Heated and moisture exchanger (HME)

Device

Heated humidifier (HH)

Device

Primary outcomes

  1. Change in muscle pressure-time product (PTPoes)

    Time frame: Baseline and 60 minutes

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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