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Trial record 51 of 670 for:    CARBON DIOXIDE AND arterial

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

Tracking Information
First Submitted Date  ICMJE November 23, 2018
First Posted Date  ICMJE November 28, 2018
Last Update Posted Date November 28, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • 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
  • patient's tolerance to the mask [ Time Frame: immediate ]
    the tolerance will be recorded using an ad hoc scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CO2 Clearance During Noninvasive Ventilation (NIV)
Official Title  ICMJE Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Hypercapnic Respiratory Failure
Intervention  ICMJE
  • Device: DiMax Zero Total face mask "R",
    a non-CO2 rebreathing device included directly in the full face mask
  • Device: traditional face mask
    a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
Study Arms  ICMJE
  • 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",
    Intervention: Device: DiMax Zero Total face mask "R",
  • Active Comparator: traditional face mask
    Traditional mask without a CO2 clearance device inserted
    Intervention: Device: traditional face mask
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: stefano nava 3333751828 stefanava@gmail.com
Contact: vittoria comellini vittoria.comellini@aosp.bo.it
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03756415
Other Study ID Numbers  ICMJE Stefano Nava1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: not allow to release individual data
Responsible Party dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Study Sponsor  ICMJE Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: stefano nava Azienda Ospedaliera Sant'Orsola
PRS Account Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP