Asynchronies in NIV With External Gas

Non-invasive Ventilation Clinical Trial

Official title:

Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884828
• Other study ID #: gasNIV
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• over 18 years of age,

• hospital admission for acute chronic respiratory failure,

• home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).

Exclusion Criteria:

• Patients with underlying psychiatric disease were excluded

Related Conditions & MeSH terms

• Non-invasive Ventilation

Intervention

Device:
• external gas during NIV
The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.

Locations

Country	Name	City	State
Spain	Cristina Lalmolda	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchronies ( yes or no)	Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV	1 day
Primary	Type of asynchronies	autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV	1 day
Secondary	Type of asynchronies pre	autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment	1 day
Secondary	Type of asynchronies post	autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV	1 day
Secondary	Asynchronies ( yes or no) pre	Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV	1 day
Secondary	Asynchronies ( yes or no) post	Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV	1 day