The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC

NCT04564859 | Completed DMC

• 1 other identifier: SKH-8302-106-NDR-05
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.

Conditions

Critically Illness

Outcome Measures

Primary Outcomes (1)

• Re-intubation rate

  Any placement of an endotracheal tube for any indication within 72 hours of extubation, censored at the first of hospital discharge or 72 hours after extubation.

  within 72 hours of extubation

Secondary Outcomes (1)

• Mortality rate

  up to 3 months

Study Arms (2)

Noninvasive Ventilation group

EXPERIMENTAL

Noninvasive Ventilation group initial setting： Insp. Pressure：12 \~ 16 centimeter of water Exp. Pressure ： 4 \~ 6 centimeter of water FiO2：Keep oxygen saturation measured by pulse oximeter：\> 92% By condition, gradually tap 2\~3 centimeter of water inspiratory positive airway pressure Keep Tidal volume：6\~10 ml/kg

Device: Heated Humidified High-Flow Nasal Cannula

Heated Humidified High-Flow Nasal Cannula group

ACTIVE COMPARATOR

Heated Humidified High-Flow Nasal Cannula group initial setting： Flow setting: 50 L/m FiO2：Keep oxygen saturation measured by pulse oximeter \> 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m

Device: Heated Humidified High-Flow Nasal Cannula

Interventions

Heated Humidified High-Flow Nasal Cannula DEVICE

Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.

Also known as: Noninvasive Ventilation

Heated Humidified High-Flow Nasal Cannula group; Noninvasive Ventilation group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Over 20 years of age
• the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days

You may not qualify if:

• Pregnancy
• Status post tracheostomy
• Neuromuscular diseases
• Signed "do not resuscitate" order
• Unplanned extubation

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• Fu Jen Catholic University: collaborator

Related Publications (1)

• Tseng CW, Chao KY, Wu HL, Lin CC, Hsu HS. Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. Sci Rep. 2023 Mar 22;13(1):4689. doi: 10.1038/s41598-023-31444-8.

  PMID: 36949116 DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Chen-Chun Lin, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 25, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 25, 2020

Record last verified: 2020-09