Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Dyspnea

Respiratory Aspiration

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.

Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Vapotherm

Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.

BIPAP

David Hui, MD

The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath.

The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.

Study Devices:

The BiPAP device is designed to help people get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels.

The Vapotherm device is also designed to deliver air in and out of the lungs. The air is warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* Group 1 will receive air through BiPAP for up to 2 hours and then air through Vapotherm for up to 2 hours.
* Group 2 will receive air through Vapotherm for up to 2 hours and then air through BiPAP for up to 2 hours.

The study staff will help you use the devices.

If you have trouble with one of the devices, you can be switched to the other device before the 2-hour period is over.

After using the first device, you will wait for up to 60 minutes before switching over to the other device. This waiting period will occur no matter if you used the first device for the full 2 hours or not.

During the waiting period, you will return to the same air delivery device and oxygen level that you were using just before you started the study. The study staff will also be checking to see if you are still eligible to use the second device.

Study Tests:

During the study period, your vital signs and level of air breathed out will be recorded using a measuring device on your chest.

Before and after using the devices, you will rate how hard it is to catch your breath.

After using the second device, you will fill out a questionnaire that has questions about which device you prefer. This should take less than 5 minutes.

Length of Study:

You will be on this study for up to 5 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.

Use of Other Drugs:

During the 4-5 hour study period, you will not be allowed to take certain drugs for standard care that may affect the study tests. These drugs include certain pain-killer drugs (such as morphine and hydromorphone), steroids (such as prednisone and dexamethasone), and inhaled drugs (such as ipratropium and salbutamol).

Any doses of inhaled drugs (regularly scheduled doses and "as needed" doses) and any "as needed" doses of pain-killer drugs and steroids that fall within the 4-5 hour study period will be put on hold and will be given to you right after the study is complete.

You may, however, choose to take these drugs, either because your shortness of breath is not controlled, or because these drugs are needed to treat other problems (such as pain). If you and your doctor decide that you should take these drugs during the study period, you will be taken off study so you can receive these drugs. The reason for stopping your study participation is that these drugs may affect how you rate your shortness of breath.

This is an investigational study. The BIPAP and Vapotherm devices are commercially available and FDA approved for delivering oxygen when medically needed, including in patients with advanced cancer. The investigational part of this study is to collect information from asking patients to rate how well the study devices may affect shortness of breath.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.

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

An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients

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.

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.

M.D. Anderson Cancer Center

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.

Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.

Group1: BiPAP Then Vapotherm

Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.

Group 2: Vapotherm Then BiPAP

Group 1: BiPAP Then Vapotherm

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

David Hui, MD, MSc, FRCPC

Completed washout period

Completed second intervention

Number of Participants Completing Study Intervention

Dyspnea NRS at the time of enrollment

Dyspnea NRS after intervention

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

Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale

Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.

First Intervention (2 Hours)

Washout Period (1 Hour)

Second Intervention (2 Hours)

Neoplasms

Neoplasm Metastasis

Recurrence

Participants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.

Participants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask.

Participants receive air through Non-Rebreather Mask for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP).

Oxygen Delivery Devices

2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.

Questionnaires

The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.

Device A is designed to get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels.

Device B is designed to deliver air in and out of the lungs. The air is warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Device C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.

Study Groups and Device Use:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

* If you are in Group 1, you will receive air through Device A for 1 hour, and then on an "as needed" basis for up to 4 hours. Then you will receive air through Device B for up to 30 minutes, followed by 30 minutes using Device C.
* If you are in Group 2, you will receive air through Device B for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device C.
* If you are in Group 3, you will receive air through Device C for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device B.

The study staff will help you use the devices. The maximum time allowed using the 3 devices is 6 hours total.

During the "as needed" use period (4 hours), you will switch between the device you were assigned to and the same air delivery device and oxygen level that you were using just before you started the study.

Study Visit:

During your study visit, the following tests and procedures will be performed:

* From your medical record, the study staff will collect information about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
* You will complete 2 questionnaires. The first asks about breathing symptoms, and the second asks about other symptoms you may be having. It should take about 15 minutes to complete these questionnaires.
* Your heart rate, breathing rate, and blood pressure will be recorded.
* The level of air you breathe out will be recorded using a measuring device on your chest.
* Before and after using the devices, you will be asked how hard it is to catch your breath and about any side effects you may be having.
* At the end of the visit, you will fill out a questionnaire that asks about which device you prefer. It should take about 5 minutes to complete this questionnaire.

Length of Study:

You will be on this study for up to 6 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.

This is an investigational study. The 3 breathing devices are commercially available and FDA approved for delivering oxygen when medically needed, including in cancer patients. It is investigational to collect information from patients to rate how well the study devices may affect shortness of breath.

Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

BiPAP-Vapotherm RCT

Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer

Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Esophageal Neoplasms

Lymphoma

Thoracic Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Esophageal Cancer

Lymphosarcoma

Different settings of CPAP and BiPAP will be tested using a home mechanical ventilator

CPAP

Robin Wijsman

J. Elshof

When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent.

With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.

The study will follow a 2-step approach.

First (Phase 1, n=10), the feasibility of short-term use of CPAP and BiPAP and its effects on (regional) lung volumes, tidal volumes and breathing frequency will be investigated in patients with intra-thoracic tumors who are planned for radiotherapy. This is necessary to select the best setting of CPAP or BiPAP with which minimal tumor motion is expected (and that is feasible for the patient).

In the second phase (n=21), the particular setting found in fase 1 is investigated: weekly repeated radiotherapy planning (4D) CT scans with and without CPAP/BiPAP will be aquired to evaluate the influence on tumor motion and dose to the target and organs at risk. Radiotherapy will be deliverd according to local protocol without the use of CPAP/BiPAP.

CPAP or BiPAP for Motion Mitigation During Radiotherapy

Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy

The primary objective is to evaluate the lung volume changes (in cm3) induced by the use of mechanical ventilation

Feasibility is expressed as a score (using a Visual Analoge Scale)

Feasibility is expressed as the duration (minutes) the participant can undergo mechanical ventilation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer	NCT00934128	Advanced Cancer...	Vapotherm BIPAP	18 Years -	M.D. Anderson Cancer Center
BiPAP-Vapotherm RCT	NCT01518140	Advanced Cancer...	Oxygen Delivery... Questionnaires	18 Years -	M.D. Anderson Cancer Center
CPAP or BiPAP for Motion Mitigation During Radiotherapy	NCT04986293	Radiotherapy Si... NSCLC Esophageal Canc... Malignant Lymph...	CPAP	18 Years -	University Medical Center Groningen
BiPAP-Vapotherm RCT	NCT01518140	Advanced Cancer...	Oxygen Delivery... Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for bipap

Every month we try and update this database with for bipap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bipap

Every month we try and update this database with for bipap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bipap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.