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

Chronic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499796
• Other study ID #: 981
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: February 13, 2018
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2018
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Hygrovent Gold

• Heated and moisture exchanger (HME)

• Heated humidifier (HH)

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Epub 2002 Sep 6. — View Citation

Lellouche F, Maggiore SM, Deye N, Taillé 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. Epub 2002 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle pressure-time product (PTPoes)		Baseline and 60 minutes