Effect of High-flow Nasal Oxygen on Extubation Outcome

COPD Clinical Trial

Official title:

Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02290548
• Other study ID #: 14MMHIS164
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2014
• Last updated: December 11, 2014
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2014
• Source: Mackay Memorial Hospital
• Contact: Kuo li Kuo, MD
• Phone: +886975835135
• Email: lmn4093[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit

Description:

The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients mechanically ventilated for > 48 hours and at least one of the following:

• > 65 y/o

• Cardiac failure as the primary indication of mechanical ventilation

• COPD

• Bronchiectasis

• Old pulmonary tuberculosis with destructive lung

• Chronic renal failure

• Neuromuscular disease

• BMI > 30

• Inability to manage respiratory secretions

• ARDS

Exclusion Criteria:

• Presence of tracheostomy

• Recent facial trauma

• Active gastro-intestinal bleeding

• Planned NIPPV support after extubation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• COPD
• Heart Failure
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• high flow nasal cannula
High flow nasal cannula used in postextubation patients

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reintubation rate		72 hours after extubation	Yes
Secondary	Need for Non-Invasive Ventilation		at day 28 after inclusion in the study	No
Secondary	ICU readmission rate due to respiratory failure		at day 28 after inclusion in the study	No
Secondary	ICU mortality rate		at day 28 after inclusion in the study	No
Secondary	ICU length of stay		at day 28 after inclusion in the study	No
Secondary	Hospital mortality		at day 28 after inclusion in the study	No
Secondary	Hospital length of stay		at day 28 after inclusion in the study	No
Secondary	Nosocomial pneumonia rate		at day 28 after inclusion in the study	No
Secondary	Desaturation ( SaO2< 90%)		72 hours after extubation	Yes
Secondary	Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)		Time Frame: 72 hours after extubation	Yes
Secondary	hypercapnia (PaCO2 > 50)		72 hours after extubation	Yes
Secondary	respiratory acidosis (arterial pH < 7.30)		72 hours after extubation	Yes
Secondary	severe tachypnea (>40/min)		72 hours after extubation	Yes