Early Non-invasive Ventilation and Progressive High Flow Oxygen Therapy Through Tracheostomy Tube Weaning Protocol in Tracheostomized Patients with Prolonged Mechanical Ventilation

Capital Medical University

Status: Active, not recruiting

Conditions: Weaning from Mechanical Ventilation; Mechanical Ventilation

Treatments: Procedure: weaning by early non-invasive ventilation and progressive high flow oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06642714

2018Z-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

weaning group

Other group

Description:

Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).

Treatment:

Procedure: weaning by early non-invasive ventilation and progressive high flow oxygen therapy