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

NCT ID: NCT02499796

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-09-30

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.

Conditions

Chronic Respiratory Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Hygrovent Gold

Intervention Type: DEVICE

Heated and moisture exchanger (HME)

Intervention Type: DEVICE

Heated humidifier (HH)

Intervention Type: DEVICE

Interventions

Hygrovent Gold

Intervention Type: DEVICE

Heated and moisture exchanger (HME)

Intervention Type: DEVICE

Heated humidifier (HH)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Annia Schreiber

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piero Ceriana, MD

Role: STUDY_CHAIR

Fondazione Salvatore Maugeri

Locations

Fondazione Salvatore Maugeri

Pavia, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 12415444 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12415445 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31270176 (View on PubMed)

Other Identifiers

981

Identifier Type: -

Identifier Source: org_study_id