Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Methylprednisolone
DrugIPS cohort only
Oxygen Therapy
Procedure/SurgeryReceive high flow oxygen therapy
Positive Air Pressure Device
DeviceUndergo NIPPV
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Arm A (NIPPV therapy)Experimental treatment 2 interventions
Group B: Arm B (high flow oxygen therapy)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 28 days from study inclusionSecondary outcomes
1
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.
Time frame
Up to 28 days2
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.
Time frame
Up to 28 days3
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.
Time frame
Up to 28 days4
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.
Time frame
Baseline up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov