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

NCT06642714 | Active Not Recruiting DMC

• 1 other identifier: 2018Z-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Weaning from Mechanical Ventilation

Keywords

tracheostomy; mechanical ventilation; non-invasive ventilation; High flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

• weaning success

  through study completion, an average of 100 days

Secondary Outcomes (9)

• mechanical ventilation days

  120 days

• 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

Study Arms (1)

weaning group

OTHER

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).

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

Interventions

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

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

weaning group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The expected survival time less than 3 months;
• Participated in another clinical study related to weaning;
• death or discharge within 2 weeks after referral;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, China

Location

Study Officials

• Jingyi Ge

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Jingyi Ge

  Beijing Rehabilitation Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: February 1, 2018
• Primary Completion: September 3, 2024
• Study Completion: October 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)