NCT06642714

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mechanical Ventilation
• Weaning from Mechanical Ventilation

Interventions

Type	Name	Description
PROCEDURE	weaning by early non-invasive ventilation and progressive high flow oxygen therapy	Step 1 Clinical stability was confirmed: (1)Without organ failure;(2)Without sepsis;(3)Stable heart rate and blood pressure without use of vascular active drugs. Step2 Reduce the support parameters of the ventilator gradually. Step3 SBT when the ventilator mode is pressure support ventilation(PSV),P+PEEP≤16cmH2O for 2 hours. Step4 ①Success of SBT: titrate based HFOT time-------connected with tracheostomy tube ,flow rate and FiO2 able to maintain oxygen saturation as assessed by pulse oximetry monitoring of at least 95%.HFOT was interrupted in cases of sighs or symptoms of distress such as oxygen desaturation, RR\>30bpm, HR\>130bpm,SBP\>180mmHg or \<90mmHg.The time was based HFOT time. When any of these conditions were present the patient was connected again to the ventilator with the same parameters before titration. The duration of SBT was increased progressively over the following day according to patient tolerance. Then gradually extending HFOT time daily according patient condition. Wh

Timeline

• Start date: 2018-02-01
• Primary completion: 2024-09-03
• Completion: 2024-10-30
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China