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

Not Applicable

Active, not recruiting

• Conditions: Mechanical Ventilation; Weaning from Mechanical Ventilation

• Registration Number: NCT06642714
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2024-09-03
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
weaning success	through study completion, an average of 100 days

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation days	120 days	the duration of mechanical ventilation
weaning duration	through study completion, an average of 120 days
Length of stay	6 months
1 year survival	1 year
Rate of extubation	through study completion, an average of 100 days
Discharge destination	12 months	At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
Mortality rate in hospital	12 months
Re-hospitalization rate within 1 year	12 months
Length of stay at HDU	6 months

Trial Locations

Locations (1)

Beijing Rehabilitation Hospital of Capital Medical University; 🇨🇳 Beijing, China