Trial Outcomes & Findings for High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer (NCT NCT00934128)

Last Updated: 2016-03-02

Results Overview

Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study. A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was \>/= baseline dyspnea level-1, or (2) their dyspnea level was \>/= 3/10 after one hour.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Minimally 1 hour, up to 5 hours

Results posted on

2016-03-02

Participant Flow

Recruitment period August 2009 to February 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Group 1: BiPAP Then Vapotherm Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.	Group 2: Vapotherm Then BiPAP Vapotherm air delivery then BiPAP.
First Intervention (2 Hours) STARTED	15	15
First Intervention (2 Hours) COMPLETED	10	13
First Intervention (2 Hours) NOT COMPLETED	5	2
Washout Period (1 Hour) STARTED	10	13
Washout Period (1 Hour) COMPLETED	3	8
Washout Period (1 Hour) NOT COMPLETED	7	5
Second Intervention (2 Hours) STARTED	3	8
Second Intervention (2 Hours) COMPLETED	3	5
Second Intervention (2 Hours) NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: BiPAP Then Vapotherm Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.	Group 2: Vapotherm Then BiPAP Vapotherm air delivery then BiPAP.
First Intervention (2 Hours) Withdrawal by Subject	0	1
First Intervention (2 Hours) Adverse Event	4	1
First Intervention (2 Hours) Treatment Delivery Order Switched	1	0
Washout Period (1 Hour) Patient preference	1	3
Washout Period (1 Hour) Pain	1	0
Washout Period (1 Hour) Too tired	1	0
Washout Period (1 Hour) Dyspnea too low to continue	4	2
Second Intervention (2 Hours) Claustrophobia/anxiety	0	3

Baseline Characteristics

High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: BiPAP Then Vapotherm n=15 Participants Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.	Group 2: Vapotherm Then BiPAP n=15 Participants Vapotherm air delivery then BiPAP.	Total n=30 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	59 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Minimally 1 hour, up to 5 hours

Outcome measures

Outcome measures
Measure	Group 1: BiPAP Then Vapotherm n=10 Participants Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.	Group 2: Vapotherm Then BiPAP n=13 Participants Vapotherm air delivery then BiPAP.
Number of Participants Completing Study Intervention Completed washout period	7 Participants	10 Participants
Number of Participants Completing Study Intervention Completed second intervention	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)

Population: One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.

Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.

Outcome measures

Outcome measures
Measure	Group 1: BiPAP Then Vapotherm n=14 Participants Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.	Group 2: Vapotherm Then BiPAP n=16 Participants Vapotherm air delivery then BiPAP.
Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale Dyspnea NRS at the time of enrollment	7 units on a scale Interval 5.0 to 8.0	6 units on a scale Interval 4.0 to 8.0
Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale Dyspnea NRS after intervention	3.4 units on a scale Interval 1.8 to 5.0	4.2 units on a scale Interval 3.1 to 5.4

Adverse Events

Group1: BiPAP Then Vapotherm

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 2: Vapotherm Then BiPAP

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group1: BiPAP Then Vapotherm n=15 participants at risk Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.	Group 2: Vapotherm Then BiPAP n=15 participants at risk Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
Eye disorders Dry eyes before intervention	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	20.0% 3/15 • Number of events 3 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Eye disorders Eye irritation before intervention	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	20.0% 3/15 • Number of events 3 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Psychiatric disorders Anxiety before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
General disorders Moist nose before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
General disorders Prong Uncomfortable before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Gastrointestinal disorders Stomach bloating before intervention	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	20.0% 3/15 • Number of events 3 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Respiratory, thoracic and mediastinal disorders Suffocating before intervention	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Gastrointestinal disorders Trouble drinking before intervention	6.7% 1/15 • Number of events 1 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	0.00% 0/15 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Gastrointestinal disorders Trouble eating before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	33.3% 5/15 • Number of events 5 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
General disorders Trouble sleeping before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	46.7% 7/15 • Number of events 7 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.
Social circumstances Trouble talking before intervention	13.3% 2/15 • Number of events 2 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.	40.0% 6/15 • Number of events 6 • Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months. Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.

Additional Information

David Hui, MD, MSc, FRCPC

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place