Trial Outcomes & Findings for Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers (NCT NCT03882723)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

5 min

Results posted on

2023-06-28

Participant Flow

This was a randomized crossover trial so each participate used all four masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow).

Participant milestones

Participant milestones
Measure	Randomized Crossover Trial With 4 NIV Masks Order of the 4 masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics PerforMax 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. 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.
Overall Study STARTED	8
Overall Study BiTrac Max Shield	8
Overall Study BiTrac™ Full Face	8
Overall Study Respironics PerforMax	8
Overall Study Respironics AF531	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This data was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Crossover Trial With 4 NIV Masks n=8 Participants Order of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics PerforMax 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. 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.
Age, Customized greater than 18	8 Participants n=8 Participants
Sex/Gender, Customized Not collected	0 Participants This data was not collected.
No history of pulmonary or cardiac disease	8 Participants n=8 Participants
No current ear infection	8 Participants n=8 Participants
No history of use of noninvasive ventilation	8 Participants n=8 Participants
no facial surgery or deformity that would interfere with the mask seal.	8 Participants n=8 Participants

PRIMARY outcome

Timeframe: 5 min

Population: The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes.

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

Outcome measures

Outcome measures
Measure	PEEP 0 n=8 Participants A PEEP of 0 cmH2O was applied to the masks.	PEEP 2 n=8 Participants A PEEP of 2 cmH2O was applied to the masks.	PEEP 4 n=8 Participants A PEEP of 4 cmH2O was applied to the masks.	PEEP 5 n=8 Participants A PEEP of 5 cmH2O was applied to the masks.
Carbon Dioxide Clearance From the Masks	1.83 percentage of CO2 inspired Interval 0.66 to 4.0	1 percentage of CO2 inspired Interval 0.33 to 2.66	0.49 percentage of CO2 inspired Interval 0.0 to 1.92	0 percentage of CO2 inspired Interval 0.0 to 0.92

SECONDARY outcome

Timeframe: 5 min

Population: The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes.

Amount of leak measured by the ventilator.

Outcome measures

Outcome measures
Measure	PEEP 0 n=8 Participants A PEEP of 0 cmH2O was applied to the masks.	PEEP 2 n=8 Participants A PEEP of 2 cmH2O was applied to the masks.	PEEP 4 n=8 Participants A PEEP of 4 cmH2O was applied to the masks.	PEEP 5 n=8 Participants A PEEP of 5 cmH2O was applied to the masks.
Leak (L/Min)	22 Liters per minute Interval 15.0 to 30.0	30 Liters per minute Interval 25.0 to 40.0	36 Liters per minute Interval 27.0 to 41.0	41 Liters per minute Interval 33.0 to 47.0

SECONDARY outcome

Timeframe: 5 minutes

Population: The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes.

Tidal volume measured by the ventilator.

Outcome measures

Outcome measures
Measure	PEEP 0 n=8 Participants A PEEP of 0 cmH2O was applied to the masks.	PEEP 2 n=8 Participants A PEEP of 2 cmH2O was applied to the masks.	PEEP 4 n=8 Participants A PEEP of 4 cmH2O was applied to the masks.	PEEP 5 n=8 Participants A PEEP of 5 cmH2O was applied to the masks.
Tidal Volume	636 milliliters Interval 503.0 to 892.0	646 milliliters Interval 496.0 to 908.0	637 milliliters Interval 498.0 to 938.0	701 milliliters Interval 481.0 to 968.0

SECONDARY outcome

Timeframe: 5 minutes

Population: The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes.

The ventilator measured the subjects' respiratory rates.

Outcome measures

Outcome measures
Measure	PEEP 0 n=8 Participants A PEEP of 0 cmH2O was applied to the masks.	PEEP 2 n=8 Participants A PEEP of 2 cmH2O was applied to the masks.	PEEP 4 n=8 Participants A PEEP of 4 cmH2O was applied to the masks.	PEEP 5 n=8 Participants A PEEP of 5 cmH2O was applied to the masks.
Respiratory Rate (BPM)	13 breaths per minute Interval 12.0 to 17.0	15 breaths per minute Interval 12.0 to 17.0	15 breaths per minute Interval 12.0 to 18.0	15 breaths per minute Interval 13.0 to 18.0

Adverse Events

Randomized Crossover Trial With 4 NIV Masks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Vines

Rush University Medical Center

Phone: 3129424408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place