CO2 Clearance During Noninvasive Ventilation (NIV)

NCT ID: NCT03756415

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-06-01

Brief Summary

In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device

Detailed Description

In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.

The subjects will be studied in the sitting position and asked to relax throughout the period of the study.

The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.

FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.

End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.

Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".

The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs.

Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.

Conditions

Acute Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mask plus CO2 removal device

a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",

Group Type: EXPERIMENTAL

DiMax Zero Total face mask "R",

Intervention Type: DEVICE

a non-CO2 rebreathing device included directly in the full face mask

traditional face mask

Traditional mask without a CO2 clearance device inserted

Group Type: ACTIVE_COMPARATOR

traditional face mask

Intervention Type: DEVICE

a traditional mask without a non-CO2 rebreathing device included directly in the full face mask

Interventions

DiMax Zero Total face mask "R",

a non-CO2 rebreathing device included directly in the full face mask

Intervention Type: DEVICE

traditional face mask

a traditional mask without a non-CO2 rebreathing device included directly in the full face mask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• COPD diagnosis
• sign inform consent
• able to tolerate the application of NIV

Exclusion Criteria

• inability to tolerate the mask
• contraindication to NIV
• cancer, neurological diseases, and need of another life support besides the ventilator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

dr. Stefano Nava

Chief of Pulmonary and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

stefano nava

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Sant'Orsola

Central Contacts

stefano nava

Role: CONTACT

stefanava@gmail.com

3333751828

vittoria comellini

Role: CONTACT

vittoria.comellini@aosp.bo.it

Other Identifiers

Stefano Nava1

Identifier Type: -

Identifier Source: org_study_id