NCT02499796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

July 8, 2015

Last Update Submit

February 13, 2018

Conditions

Chronic Respiratory Failure

Keywords

Invasive mechanical ventilationHumidifying devicesRespiratory mechanics

Outcome Measures

Primary Outcomes (1)

  • Change in muscle pressure-time product (PTPoes)

    Baseline and 60 minutes

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Device: Hygrovent GoldDevice: Heated and moisture exchanger (HME)Device: Heated humidifier (HH)

Interventions

Hygrovent GoldDEVICE
Single Arm
Heated and moisture exchanger (HME)DEVICE
Single Arm
Heated humidifier (HH)DEVICE
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hypercapnic respiratory failure (PaCO2 of 45 mmHg or more)
  • Long-term mechanical ventilation via tracheostomy
  • Clinical stability

You may not qualify if:

  • Non collaborative subjects
  • Acute respiratory failure
  • Haemodynamic instability
  • Encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Salvatore Maugeri

Pavia, 27100, Italy

Location

Related Publications (3)

  • 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.

    PMID: 12415444BACKGROUND

  • 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.

    PMID: 12415445BACKGROUND

  • 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.

    PMID: 31270176DERIVED

Study Officials

  • Piero Ceriana, MD

    Fondazione Salvatore Maugeri

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 16, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

IT(1)