Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients

Sang-Min Lee98 enrolled

Overview

This clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using T-piece.

We project to test the effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients. Patients will be randomly assigned to undergo a spontaneous breathing trial in one of two ways: with a T-piece therapy or with high flow oxygen therapy. Primary end-points are rate of weaning failure and rate of reintubation within 48 hr of extubation. Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation. Secondary end-points are ICU mortality, in-hospital mortality, ICU length of stay, time to reintubation after extubation. Study sample was calculated to detect ability of high flow oxygen therapy to reduce weaning failure from 42 to 15 percent, at two-tailed alpha error of 5% and power of 85% and 98 patients are needed in each arm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Weaning Mechanical Ventilation Extubation

Interventions

High flow oxygen therapy in spontaneous breathing trialPROCEDURE

Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18 years or more, both gender * Receiving endotracheal intubation and mechanical ventilation for more than 12 hours * Recovery from the precipitating illness * Weaning readiness according to the following criteria : 1. Respiratory criteria : 1. PaO2:FIO2 \>150 with FIO2 ≤0.4, PEEP \<8 cm H2O 2. Arterial pH \>7.35 3. Rapid shallow breathing index (RSBI) \< 105 4. Maximum inspiratory pressure (MIP) \< -20 cm H20 2. Clinical criteria : 1. Absence of electrocardiographic signs of myocardial ischemia 2. No vasoactive drugs, or vital signs are stable with using vasoactive drugs 3. Heart rate \<140/min, 4. Hemoglobin \>8 g/dL 5. Temperature \<38°C 6. No need for sedatives, or mental status are stable with sedatives 7. Presence of respiratory stimulus, and appropriate spontaneous cough 8. Absence of excessive tracheobronchial secretions Exclusion Criteria: * Tracheostomy status * Decision to stop life-supportive therapies before enrollment

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Rate of weaning failure

Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation

Time frame: Day 2

Secondary Outcomes

ICU mortality

Death in ICU

Time frame: From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.

In-hospital mortality

Death in hospital

Time frame: From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.

ICU length of stay

Duration in days from day of first spontaneous breathing trial to day of discharge from the ICU

Time frame: Through the study completion, an average of 1 weeks

Time to reintubation after extubation

Duration in times from time of extubation to time of reintubation

Time frame: From the date of extubation until the date of reintubation, assessed up to 1 weeks.

Rate of reintubation within 48 hr of extubation

Reintubation within 48 hr of extubation

Time frame: Day 2

Central Contacts

Sang-Min Lee, MD

CONTACT

82-02-2072-0833 sangmin2@snu.ac.kr

Hong Yeul Lee, MD

CONTACT

82-02-2072-1094 takumama@naver.com

Data from ClinicalTrials.gov

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