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CO2 Clearance During Noninvasive Ventilation (NIV)

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ClinicalTrials.gov Identifier: NCT03756415
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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

Condition or disease Intervention/treatment Phase
Acute Hypercapnic Respiratory Failure Device: DiMax Zero Total face mask "R", Device: traditional face mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mask plus CO2 removal device
a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
Device: DiMax Zero Total face mask "R",
a non-CO2 rebreathing device included directly in the full face mask

Active Comparator: traditional face mask
Traditional mask without a CO2 clearance device inserted
Device: traditional face mask
a traditional mask without a non-CO2 rebreathing device included directly in the full face mask




Primary Outcome Measures :
  1. changes in arterial blood gases (ABGs) [ Time Frame: immediate ]
    Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery

  2. patient's tolerance to the mask [ Time Frame: immediate ]
    the tolerance will be recorded using an ad hoc scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756415


Contacts
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Contact: stefano nava 3333751828 stefanava@gmail.com
Contact: vittoria comellini vittoria.comellini@aosp.bo.it

Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: stefano nava Azienda Ospedaliera Sant'Orsola

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Responsible Party: dr. Stefano Nava, Chief of Pulmonary and Critical Care, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03756415     History of Changes
Other Study ID Numbers: Stefano Nava1
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not allow to release individual data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms