RECRUITING

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

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Conditions

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients with Hypoxemic Respiratory Failure and Malignancies

Quick Facts

Study Start:2015-10-06
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02464696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =\< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =\< 357
  2. * Have a diagnosed malignancy
  3. * 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
  4. * Probability of survival is at least 6 months
  1. * Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry
  2. * Clinical evidence of left heart failure as the main etiology for respiratory compromise
  3. * Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
  4. * Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure
  5. * Evidence of accessory respiratory muscle use with breathing
  6. * Shock (need for vasopressor therapy or mean arterial pressure \[MAP\] \< 60 despite fluid administration)
  7. * Oliguric acute renal failure (urine output \< 500 ml/day) unless already on hemodialysis
  8. * Patient already on NIPPV at the time of screening
  9. * pH \< 7.30 or partial pressure of carbon dioxide (pCO2) \> 50 (if available)
  10. * Fixed upper airway obstruction
  11. * Airway or facial trauma that would hinder the use of a NIPPV mask
  12. * 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)
  13. * 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)
  14. * Glasgow Coma Scale (GCS) \< 8 or inadequate airway protective reflexes
  15. * Undrained pneumothorax/pneumomediastinum
  16. * 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
  17. * Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
  18. * Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)
  19. * Inability to cooperate with NIPPV
  20. * Refusal to receive NIPPV
  21. * Respiratory arrest

Contacts and Locations

Study Contact

Nisha Rathi, MD
CONTACT
713-792-5040
NRathi@mdanderson.org

Principal Investigator

Nisha Rathi
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Nisha Rathi, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-10-06
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2015-10-06
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm