Effect of HFNO Therapy on Respiratory Effort After Extubation
Launched by HENRIK ENDEMAN · Dec 14, 2022
Trial Information
Current as of February 05, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is studying the effects of High Flow Nasal Oxygen (HFNO) therapy on breathing efforts in adult patients who have just been taken off a ventilator (extubation). The goal is to see if using HFNO helps patients breathe more easily and reduces the chance that they will need to be put back on the ventilator. The researchers will compare two groups: one group will receive conventional oxygen therapy and the other will receive HFNO after extubation. They will measure how hard patients have to work to breathe (respiratory effort) and how well their lungs are functioning in the days following extubation.
To be eligible for this trial, participants must be adults aged 18 or older who have been on a ventilator for more than 48 hours and have successfully completed a breathing test. Patients with specific conditions, such as certain sleep apnea syndromes or diaphragm paralysis, will not be included. If patients choose to participate, they will be randomly assigned to one of the two oxygen therapy groups after being extubated, and will be monitored for breathing effort and lung function during their recovery. This study aims to provide more information on how different oxygen therapies can support patients after they leave the ventilator.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Aged ≥ 18 years
- • Receiving IMV \> 48 hours for any cause
- • Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
- • Provided written informed consent, through legal representatives on indication
- Exclusion Criteria:
- • Any clinical situation preventing appropriate execution of study procedures
- • The presence of a tracheostomy
- • Any feature that precludes HFNO-initiation
- • Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
- • Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
- • Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing)
- • Known pregnancy or current breast-feeding
About Henrik Endeman
Henrik Endeman is a dedicated clinical trial sponsor committed to advancing medical research through innovative and ethical study designs. With a strong focus on patient safety and regulatory compliance, Endeman fosters collaboration among researchers, healthcare professionals, and stakeholders to facilitate the development of groundbreaking therapies. Leveraging extensive expertise in clinical operations and strategic planning, he aims to streamline trial processes and enhance data integrity, ultimately contributing to the improvement of health outcomes and the acceleration of drug development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rotterdam, , Netherlands
Rotterdam, , Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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