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OpenTrials
Completed

NCT Number: NCT03882723

Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers

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.

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Key information

Conditions

CO2 Clearance Mask Comfort Rebreathing Exhaled Gas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluated 4 masks used for NIV with mechanical ventilators

Device

Order of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow) 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 outcomes

  1. Carbon Dioxide Clearance From the Masks

    Time frame: 5 min

    Measured the percentage of CO2 being re-breathed or inspired using a nasal cannula and sidestream end-tidal CO2 monitor.

Secondary outcomes

  1. Leak (L/Min)

    Time frame: 5 min

    Amount of leak measured by the ventilator.

  2. Tidal Volume

    Time frame: 5 minutes

    Tidal volume measured by the ventilator.

  3. Respiratory Rate (BPM)

    Time frame: 5 minutes

    The ventilator measured the subjects' respiratory rates.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.