Trial Outcomes & Findings for Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure (NCT NCT03832387)

NCT ID: NCT03832387

Last Updated: 2019-06-04

Results Overview

Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: from randomization to 1 week
• Results posted on: 2019-06-04

Participant Flow

Participant milestones

Measure	Non-invasive Mechanical Ventilation Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Overall Study STARTED	38	39
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Non-invasive Mechanical Ventilation Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Overall Study Protocol Violation	2	6
Overall Study EXCLUSION CRITERIA	3	1

Baseline Characteristics

Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure

Baseline characteristics by cohort

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask	Total n=65 Participants Total of all reporting groups
Age, Continuous	66 YEARS n=93 Participants	62 YEARS n=4 Participants	64 YEARS n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	17 Participants n=4 Participants	33 Participants n=27 Participants
Region of Enrollment Spain	33 participants n=93 Participants	32 participants n=4 Participants	65 participants n=27 Participants

PRIMARY outcome

Timeframe: from randomization to 1 week

Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Intubation	10 participants	23 participants

SECONDARY outcome

Timeframe: from randomization to 3 weeks

Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Tracheotomy	6 Participants	10 Participants

SECONDARY outcome

Timeframe: From intensive care unit admission to 2 months

Duration of stay at intensive care unit

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Intensive Care Unit Length of Stay	18 days Interval 9.0 to 34.0	26 days Interval 13.0 to 36.0

SECONDARY outcome

Timeframe: From hospital admission to 3 months

Duration of stay at hospital

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Hospital Length of Stay	41 days Interval 26.0 to 68.0	44 days Interval 30.0 to 53.0

SECONDARY outcome

Timeframe: From randomization to one week

Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy	37 HOURS Interval 22.0 to 80.0	10 HOURS Interval 2.0 to 24.0

SECONDARY outcome

Timeframe: From start of mechanical ventilation to one month

Duration of mechanical ventilation until unsupported ventilation

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Duration of Global Mechanical Ventilation	14 days Interval 7.0 to 22.0	14 days Interval 7.0 to 29.0

SECONDARY outcome

Timeframe: From intensive care unit admission to 2 months

Mortality during intensive care unit stay

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Intensive Care Unit Mortality	6 Participants	6 Participants

SECONDARY outcome

Timeframe: From hospital admission to 3 months

Mortality during hospital stay

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Hospital Mortality	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 90 days after randomization

Mortality at 90 days after randomization

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of 90 Days Mortality	13 Participants	9 Participants

SECONDARY outcome

Timeframe: From start of mechanical ventilation to 2 months

Percentage of participants with lung infection during intensive care unit stay

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Ventilator Associated Pneumonia	3 Participants	8 Participants

SECONDARY outcome

Timeframe: From intensive care unit admission to 2 months

Percentage of participants with urinary tract infection during intensive care unit stay

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Urinary Tract Infection	6 Participants	7 Participants

SECONDARY outcome

Timeframe: From intensive care unit admission to 2 months

Percentage of participants with blood infection during intensive care unit stay

Outcome measures

Measure	Non-invasive Mechanical Ventilation n=33 Participants Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Non-invasive mechanical ventilation Continuous positive airway pressure	Venturi Mask n=32 Participants For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2. The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Venturi mask Reservoir mask
Rate of Bacteremia	3 Participants	3 Participants

Adverse Events

Non-invasive Mechanical Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Venturi Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. ALBERTO BELENGUER MUNCHARAZ

HOSPITAL GENERAL UNIVERSITARIO DE CASTELLÓN

Phone: 96472500

Email: belengueralberto8@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place