Clinical trial NCT06642714: Early Non-invasive Ventilation and Progressive High Flow Oxygen Therapy Through Tracheostomy Tube Weaning Protocol in Tracheostomized Patients with Prolonged Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Weaning from Mechanical Ventilation
Keywords: tracheostomy
mechanical ventilation
non-invasive ventilation
High flow oxygen therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (MV),failure to wean from MV.MV 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 load/capacity 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 ventilation(NIV) 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 disease(COPD) .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 therapy(HFOT)allows a more accurate FiO2.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* After tracheotomy;
* Patients who met the definition of long-term mechanical ventilation (requiring invasive mechanical ventilation for more than 6 hours per day for more than 21 consecutive days);
* willing to participate in this study and signed the informed consent.

Exclusion Criteria:

* The expected survival time less than 3 months;
* Participated in another clinical study related to weaning;
* death or discharge within 2 weeks after referral;
* Unable to cooperate with the study for any reason or considered not suitable for inclusion in the trial by the investigators;

Primary outcomes:
measure: weaning success
timeFrame: through study completion, an average of 100 days
Secondary outcomes:
measure: mechanical ventilation days
timeFrame: 120 days
measure: weaning duration
timeFrame: through study completion, an average of 120 days
measure: Length of stay
timeFrame: 6 months
measure: 1 year survival
timeFrame: 1 year
measure: Rate of extubation
timeFrame: through study completion, an average of 100 days
measure: Discharge destination
timeFrame: 12 months
measure: Mortality rate in hospital
timeFrame: 12 months
measure: Re-hospitalization rate within 1 year
timeFrame: 12 months
measure: Length of stay at HDU
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Rehabilitation Hospital of Capital Medical University
Study officials:
affiliation: Study Principal Investigator
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Rehabilitation Hospital of Capital Medical University
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
References: