Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03882723
Recruitment Status : Enrolling by invitation
First Posted : March 20, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
This study will be a randomized crossover trial that will be conducted at Rush University. The study will be conducted with 20 healthy volunteers who will be placed on ICU ventilator operating in the NIPPV mode. All subjects will perform 15 minutes of breathing on NIPPV on each mask of the 4 different masks (2 oronasal and 2 full face masks) that are randomly selected. Breathing through each mask will be followed by a 5- minute wash out period between masks. End tidal Carbon Dioxide (EtCO2) will be sampled nasal/oral. Different levels of EPAP will be set and CO2 clearance will be monitored. Additionally, subjective mask comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable.

Condition or disease Intervention/treatment Phase
CO2 Clearance Mask Comfort Rebreathing Exhaled Gas Device: Evaluated masks used for NIV with mechanical ventilators Not Applicable

Detailed Description:

This study will be a randomized crossover trial that will be conducted at Rush University.

Normal volunteers will be recruited from Rush University Medical Centers. Volunteers will be screened with inclusion and exclusion criteria and an informed consent is required in order for them to participate. Demographic (age, gender, ethnicity) will be obtained.

Also, initial baseline vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be obtained. EtCO2 will be obtained at baseline and periodically using an oral/nasal sample line with the CapnostreamTM 20p monitor (Medtronic, Minneapolis, MN). The study will use a double limb circuit ICU ventilator Puritan Bennett™ (Medtronic, Dublin, Ireland). Investigators will evaluate 4 NIPPV masks (2 oronasal masks and 2 full face masks).

Oronasal masks will be labeled as group A and numbered as A1 and A2; while full face masks will be labeled group B and numbered as B1 and B2. Order of the masks will be randomly chosen in two steps. First steps will be choosing A or B then randomly assign mask in each of these groups. Investigators will randomly assign mask in group A or B by drawing an initial mask from the group and then continue the sequence of masks from that point. For example, investigators randomly chose group A, then randomly chose A2, the sequence will be A2, A1. Then Investigators would randomly choose B2, then the sequence would be B2, B1. All subjects will perform 15 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 while IPAP remains at 5 higher than EPAP. EtCO2 will be collected at 4:00, 4:30 and 5:00 minute mark. These three measures should differ by less than 20% of their average. Also, subjective mask ORA: 18011502-IRB01 Date IRB Approved: 3/30/2018 Amendment Date: 5/11/2018 comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized crossover trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Carbon Dioxide (CO2) Clearance From Various Face Masks in Normal Volunteers at Various Level of Expiratory Positive Airway Pressure (EPAP) When Using a Non-Invasive Positive Pressure Ventilation (NIPPV)
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Active Comparator: BiTrac MaxShield™ with standard elbow (FFM)
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
Device: Evaluated masks used for NIV with mechanical ventilators
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.

Active Comparator: BiTrac™ Full Face with standard elbow
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
Device: Evaluated masks used for NIV with mechanical ventilators
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.

Active Comparator: Respironics PerforMax with standard elbow
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
Device: Evaluated masks used for NIV with mechanical ventilators
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.

Active Comparator: Philips Respironics AF531 with standard elbow
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
Device: Evaluated masks used for NIV with mechanical ventilators
Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.




Primary Outcome Measures :
  1. Carbon dioxide clearance from the Masks [ Time Frame: 5 min ]
    Measured the amount or fraction of CO2 being re-breathed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects greater than 18 years old.

Exclusion Criteria:

  • Prior history of NIPPV as a patient.
  • Facial surgery or deformity
  • Ear infection
  • History of pulmonary or cardiac disease

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): NCT03882723


Locations
Layout table for location information
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Layout table for investigator information
Study Chair: David Vines, MHS Rush University Medical Center

Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03882723     History of Changes
Other Study ID Numbers: ORA: 18011502-IRB01
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No