Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642714
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Early Non-invasive Ventilation and Progressive High Flow Oxygen Therapy Through Tracheostomy Tube Weaning Protocol in Tracheostomized Patients with Prolonged Mechanical Ventilation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Non-invasive Ventilation and Progressive High Flow Oxygen Therapy Through Tracheostomy Tube Weaning Protocol in Tracheostomized Patients with Prolonged Mechanical Ventilation a Prospective Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of our study was to assess the feasibility of an early NIV and progressive HFOT through tracheostomy tube weaning protocol implemented by tracheostomized patients with PMV referred to a specialized weaning unit of a rehabilitation hospital
Detailed Description:
The most common indications for tracheostomy are acute respiratory failure with demonstrate or expected prolonged duration of mechanical ventilation MVfailure to wean from MVMV is associated with several complications Placement of a long-term airway tracheostomy is also associated with short and long term risks As more patients with multiple co-morbidities undergo tracheostomy and develop difficulty with weaning new innovative concepts are urgently needed for their management Surprisingly there is very little data dealing with tracheostomized patients in weaning from mechanical ventilation and subsequent tracheostomy tube decannulation
PMV patients were not able to sustain completely unsupported breathing since their loadcapacity balance was impaired Spontaneous breathing trial is not suitable for PMV patients
For these reasons PMV patients are often transferred to specialized weaning units with multidisciplinary teams which offer advanced weaning protocols and physiotherapists The role of non-invasive ventilationNIV in MV patients with tracheostomy tube to facilitate both weaning off from the ventilator and removal of the tracheostomy tube has a solid physiological rationale but most clinical evidence is derived from limited observational studies And mainly focus on patients with chronic obstructive pulmonary diseaseCOPD Besides most NIV delivered through the facial interface while the tracheostomy tube is capped This was difficult to tolerate for patients with poor lung function and upper airway obstruction Then delayed NIV transfer High flow oxygen therapyHFOTallows a more accurate FiO2
PMV patients were not able to sustain completely unsupported breathing since their loadcapacity balance was impaired Spontaneous breathing trial is not suitable for PMV patients
For these reasons PMV patients are often transferred to specialized weaning units with multidisciplinary teams which offer advanced weaning protocols and physiotherapists The role of non-invasive ventilationNIV in MV patients with tracheostomy tube to facilitate both weaning off from the ventilator and removal of the tracheostomy tube has a solid physiological rationale but most clinical evidence is derived from limited observational studies And mainly focus on patients with chronic obstructive pulmonary diseaseCOPD Besides most NIV delivered through the facial interface while the tracheostomy tube is capped This was difficult to tolerate for patients with poor lung function and upper airway obstruction Then delayed NIV transfer High flow oxygen therapyHFOTallows a more accurate FiO2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None