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

Not Applicable

Completed

• Conditions: Chronic Respiratory Failure
• Interventions: Device: Hygrovent Gold; Device: Heated and moisture exchanger (HME); Device: Heated humidifier (HH)

• Registration Number: NCT02499796
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Hygrovent Gold	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
Single Arm	Heated and moisture exchanger (HME)	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
Single Arm	Heated humidifier (HH)	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

Primary Outcome Measures

Name	Time	Method
Change in muscle pressure-time product (PTPoes)	Baseline and 60 minutes

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Pavia, Italy