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Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone
Oxygen Therapy
Positive Air Pressure Device
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357
  • Have a diagnosed malignancy
  • Chest radiograph or computed tomography (CT) scan within =< 3 months prior to study enrollment rules out primary or metastatic malignancy in the lungs or pleural space as a significant cause of respiratory insufficiency
  • Probability of survival is at least 6 months

Exclusion Criteria:

  • Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry
  • Clinical evidence of left heart failure as the main etiology for respiratory compromise
  • Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
  • Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure
  • Evidence of accessory respiratory muscle use with breathing
  • Shock (need for vasopressor therapy or mean arterial pressure [MAP] < 60 despite fluid administration)
  • Oliguric acute renal failure (urine output < 500 ml/day) unless already on hemodialysis
  • Patient already on NIPPV at the time of screening
  • pH < 7.30 or partial pressure of carbon dioxide (pCO2) > 50 (if available)
  • Fixed upper airway obstruction
  • Airway or facial trauma that would hinder the use of a NIPPV mask
  • Uncontrolled tachy or bradyarrhythmia or active myocardial ischemia defined as either: atrial fibrillation with rapid ventricular response (heart rate [HR] > 120 beats per minute [bpm]), ventricular tachycardia or nonsustained ventricular tachycardia (any rate), supraventricular tachycardia (any rate), third degree heart block (any rate), heart rate less than 40 beats per minute (regardless of the rhythm)
  • Active myocardial ischemia defined as a clinical presentation at the time of screening consistent with acute coronary syndrome which includes unstable angina and electrocardiogram (EKG) changes suggestive of an either an acute ST elevation myocardial infarction (new ST elevations or new left bundle branch block) or acute non-ST elevation myocardial infarction (new ST depressions, new T wave inversions)
  • Glasgow Coma Scale (GCS) < 8 or inadequate airway protective reflexes
  • Undrained pneumothorax/pneumomediastinum
  • Copious secretions (> 20 cc's of sputum production per hour or significant hemoptysis defined as > 100 cc's of hemoptysis in a 24 hour period
  • Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
  • Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)
  • Inability to cooperate with NIPPV
  • Refusal to receive NIPPV
  • Respiratory arrest

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (NIPPV therapy)

Arm B (high flow oxygen therapy)

Arm Description

Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital.

Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Percent of patients who require intubation or meet criteria for intubation
Fisher's exact test or a chi-squared test will be used to assess the association between two categorical variables. The intubation rate by 28 days and 95% confidence intervals will be estimated for each treatment arm. Logistic regression will be utilized to assess the effect of patient prognostic factors on the intubation rate by 28 days.

Secondary Outcome Measures

Time to intubation
The Kaplan-Meier method will be used to estimate the time-to-event distribution for each treatment group, and the median time will be provided. The log-rank test will be used to examine the time-to-event distribution of the active treatment group versus that of the control. Time to intubation rate at different time points will be provided by treatment group (i.e. at 7 days, 14 days, 21 days, and 28 days). Since there might be other competing risks for intubation, a competing risk analysis will be performed treating these early events as a competing event for intubation.
Intensive care unit length of stay
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the non-invasive positive pressure ventilation (NIPPV) arm and the control arm.
Hospital length of stay
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.
Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.

Full Information

First Posted
June 3, 2015
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02464696
Brief Title
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
Official Title
A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2015 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized clinical trial studies how well non-invasive ventilation works in reducing the need for intubation, or placement of a tube in the windpipe, in patients with cancer and respiratory failure. Respiratory failure is a condition in which not enough oxygen passes from the lungs to the blood, and is a common cause of admission to the emergency room in patients with hematological and solid tumor patients. Non-invasive positive pressure ventilation (NIPPV) is a method of delivering oxygen using a mask. It is not yet known whether NIPPV is better at improving the amount of oxygen in the blood, reducing shortness of breath, and the need for intubation than standard high flow oxygen (a tube with 2 prongs placed in the nostrils) in patients with cancer and respiratory failure.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the percent of patients who meet criteria for intubation within 28 days of study inclusion. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (NIPPV THERAPY): Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital. ARM B (HIGH FLOW OXYGEN THERAPY): Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician. IDIOPATHIC PULMONARY SYNDROME (IPS) SUBGROUP (INCLUDING DIFFUSE ALVEOLAR HEMORRHAGE): Patients with IPS receive methylprednisolone daily on days 0-48 and every other day (QOD) on days 49-55 in parallel with NIPPV or oxygen therapy, with a taper at the discretion of the treating physician. After completion of study, patients are followed up until day 100.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (NIPPV therapy)
Arm Type
Experimental
Arm Description
Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital.
Arm Title
Arm B (high flow oxygen therapy)
Arm Type
Active Comparator
Arm Description
Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort
Intervention Description
IPS cohort only
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive high flow oxygen therapy
Intervention Type
Device
Intervention Name(s)
Positive Air Pressure Device
Intervention Description
Undergo NIPPV
Primary Outcome Measure Information:
Title
Percent of patients who require intubation or meet criteria for intubation
Description
Fisher's exact test or a chi-squared test will be used to assess the association between two categorical variables. The intubation rate by 28 days and 95% confidence intervals will be estimated for each treatment arm. Logistic regression will be utilized to assess the effect of patient prognostic factors on the intubation rate by 28 days.
Time Frame
Up to 28 days from study inclusion
Secondary Outcome Measure Information:
Title
Time to intubation
Description
The Kaplan-Meier method will be used to estimate the time-to-event distribution for each treatment group, and the median time will be provided. The log-rank test will be used to examine the time-to-event distribution of the active treatment group versus that of the control. Time to intubation rate at different time points will be provided by treatment group (i.e. at 7 days, 14 days, 21 days, and 28 days). Since there might be other competing risks for intubation, a competing risk analysis will be performed treating these early events as a competing event for intubation.
Time Frame
Up to 28 days
Title
Intensive care unit length of stay
Description
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the non-invasive positive pressure ventilation (NIPPV) arm and the control arm.
Time Frame
Up to 28 days
Title
Hospital length of stay
Description
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.
Time Frame
Up to 28 days
Title
Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Description
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.
Time Frame
Baseline up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357 Have a diagnosed malignancy Chest radiograph or computed tomography (CT) scan within =< 3 months prior to study enrollment rules out primary or metastatic malignancy in the lungs or pleural space as a significant cause of respiratory insufficiency Probability of survival is at least 6 months Exclusion Criteria: Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry Clinical evidence of left heart failure as the main etiology for respiratory compromise Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure Evidence of accessory respiratory muscle use with breathing Shock (need for vasopressor therapy or mean arterial pressure [MAP] < 60 despite fluid administration) Oliguric acute renal failure (urine output < 500 ml/day) unless already on hemodialysis Patient already on NIPPV at the time of screening pH < 7.30 or partial pressure of carbon dioxide (pCO2) > 50 (if available) Fixed upper airway obstruction Airway or facial trauma that would hinder the use of a NIPPV mask Uncontrolled tachy or bradyarrhythmia or active myocardial ischemia defined as either: atrial fibrillation with rapid ventricular response (heart rate [HR] > 120 beats per minute [bpm]), ventricular tachycardia or nonsustained ventricular tachycardia (any rate), supraventricular tachycardia (any rate), third degree heart block (any rate), heart rate less than 40 beats per minute (regardless of the rhythm) Active myocardial ischemia defined as a clinical presentation at the time of screening consistent with acute coronary syndrome which includes unstable angina and electrocardiogram (EKG) changes suggestive of an either an acute ST elevation myocardial infarction (new ST elevations or new left bundle branch block) or acute non-ST elevation myocardial infarction (new ST depressions, new T wave inversions) Glasgow Coma Scale (GCS) < 8 or inadequate airway protective reflexes Undrained pneumothorax/pneumomediastinum Copious secretions (> 20 cc's of sputum production per hour or significant hemoptysis defined as > 100 cc's of hemoptysis in a 24 hour period Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting) Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment) Inability to cooperate with NIPPV Refusal to receive NIPPV Respiratory arrest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisha Rathi, MD
Phone
713-792-5040
Email
NRathi@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisha Rathi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nisha Rathi
Phone
713-792-5040
Email
NRathi@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Nisha Rathi

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure

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