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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Weaning Mechanical Ventilation Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spontaneous breathing trial with T-piece

Patients were randomized to undergo a spontaneous breathing trial with T-piece that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Spontaneous breathing trial with high flow oxygen therapy

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.

Group Type EXPERIMENTAL

High flow oxygen therapy in spontaneous breathing trial

Intervention Type PROCEDURE

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.

Interventions

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High flow oxygen therapy in spontaneous breathing trial

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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