Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure

NCT03832387 | Completed Results

• 1 other identifier: HGCS03
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus oxygen therapy in patients with extubation failure was evaluated. A clinical trial was conducted that included patients who underwent mechanical ventilation and developed acute respiratory failure after extubation. After extubation failure, thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.

Conditions

Respiratory Failure

Keywords

Non-invasive mechanical ventilation; Oxygen therapy; Extubation failure

Outcome Measures

Primary Outcomes (1)

• Rate of Intubation

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

  from randomization to 1 week

Secondary Outcomes (11)

• Rate of Tracheotomy

  from randomization to 3 weeks

• Intensive Care Unit Length of Stay

  From intensive care unit admission to 2 months

• Hospital Length of Stay

  From hospital admission to 3 months

• Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy

  From randomization to one week

• Duration of Global Mechanical Ventilation

  From start of mechanical ventilation to one month

Study Arms (2)

Non-invasive mechanical ventilation

EXPERIMENTAL

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.

Device: Non-invasive mechanical ventilation; Device: Continuous positive airway pressure

Venturi mask

ACTIVE COMPARATOR

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.

Device: Venturi mask; Device: Reservoir mask

Interventions

Non-invasive mechanical ventilation DEVICE

Non-invasive mechanical ventilation

Continuous positive airway pressure DEVICE

Non-invasive mechanical ventilation

Venturi mask DEVICE

Venturi mask

Reservoir mask DEVICE

Venturi mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical and surgical ICU patients with 18 years of age or older
• First episode of mechanical ventilation for more than 24 hours

You may not qualify if:

• Structural neurological disorder
• Acute toxic-metabolic neurological encephalopathy with neurological deficit \[estimated by a Glasgow Coma Score (GCS) \<14 points\] at the time of weaning
• Neuromuscular disease
• Chronic obstructive pulmonary disease (COPD) receiving NIV
• Limitation of life support therapy during their admission
• Tracheostomized patients
• Spinal cord injuries
• Scheduled surgical procedure during the 48 hours following extubation
• Intensive care unit readmission
• Transfer to another centre
• Contraindication to non-invasive mechanical ventilation

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead

Study Sites (1)

Hospital General Universitari Castello

Castellon, Castello, 12004, Spain

Location

Related Publications (1)

• Belenguer-Muncharaz A, Mateu-Campos ML, Vidal-Tegedor B, Ferrandiz-Selles MD, Mico-Gomez ML, Altaba-Tena S, Arlandis-Tomas M, Alvaro-Sanchez R, Rodriguez-Martinez E, Rodriguez-Portillo J. Noninvasive ventilation versus conventional oxygen therapy after extubation failure in high-risk patients in an intensive care unit: a pragmatic clinical trial. Rev Bras Ter Intensiva. 2021 Oct 25;33(3):362-373. doi: 10.5935/0103-507X.20210059. eCollection 2021.

  PMID: 35107547 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Positive-Pressure Respiration

Limitations and Caveats

Long period of inclusion of patients due to being a single-centre study, strict exclusion criteria; low extubation failure probably due to prolongation of MV until extubation; Lastly, direct use of NIV in eligible patients after extubation failure.

Results Point of Contact

• Title: Dr. ALBERTO BELENGUER MUNCHARAZ
• Organization: HOSPITAL GENERAL UNIVERSITARIO DE CASTELLÓN

belengueralberto8@gmail.com

96472500

Study Officials

• ALBERTO BELENGUER MUNCHARAZ

  HOSPITAL GENERAL UNIVERSITARIO CASTELLON

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: STUDY GROUP: Non-invasive ventilation using BiPAP Vision and continuous positive airway pressure (CPAP) systems CONTROL GROUP: Oxygen therapy

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 6, 2019
• Study Start: March 29, 2009
• Primary Completion: June 4, 2016
• Study Completion: September 4, 2016
• Last Updated: June 4, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)