Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation

NCT00977002 | Unknown Phase 3

• 1 other identifier: upeclin/HC/FMB-Unesp-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Child extubation failure range from 4.1% to 19%. Studies in adults and children showed that extubation failure increases mortality mainly in those who need reintubation as this is a invasive procedure associated with many complications. Therefore, patients are reintubated when they worsen, which can contribute to organ dysfunction and increased mortality. Positive Pressure Noninvasive ventilation (PPNIV) has been proposed as a way to treat acute respiratory distress, avoiding complications of intubation and invasive ventilation. Most of the studies in adults are not conclusive on the benefits of PPNIV as a way to treat post-extubation acute respiratory distress. However, studies that evaluated the early use of PPNIV in post-extubation period as a way to prevent respiratory failure tend to show some advantages as decrease of reintubation, decrease number of respiratory distress, decrease of hospital infection frequency and lower mortality rate in the intensive care unit (ICU) for those who use PPNIV. In a prospective study on the use of PPNIV in 114 children, Essouri at al avoided invasive ventilation in 77%, being the group in patients with post-extubation respiratory distress. As far as the investigators know there is not any randomized, controlled study in children examining the PPNIV as a way to prevent post-extubation respiratory distress. The investigators' hypothesis is that PPNIV decreases the extubation failure rate and, as a consequence, the Pediatric Intensive Care Unit (PICU) and hospital length of stay, and mortality rate. The objective is to compare PPNIV and inhalatory O2 (catheter or facial mask) in children after extubation, evaluating the need of reintubation, hospital and PICU mortality rate and length of stay in PICU and hospital.

Conditions

Extubation Failure; Acute Respiratory Failure Post Extubation

Keywords

noninvasive ventilation; extubation; Respiratory failure; reintubation

Outcome Measures

Primary Outcomes (1)

• Prevention of reintubation

  48 hours

Secondary Outcomes (2)

• decrease of PICU and hospital mortality

  28 days

• decrease of hospital and PICU length of stay

  28 days

Study Arms (2)

PPNIV

EXPERIMENTAL

Patient randomized to this group will be ventilated with Positive Pressure Noninvasive Ventilation post extubation

Other: Positive Pressure Noninvasive ventilation

O2I

ACTIVE COMPARATOR

Patient randomized to this group will be submitted to traditional oxygen therapy post extubation

Other: Inhalatory O2

Interventions

Positive Pressure Noninvasive ventilation OTHER

Patients randomized to this group are submitted to positive pressure noninvasive ventilation for 12 hours or more. Children younger than one year use nasal prong and older than one year use nasal or facial mask. A blood gas is collected in the moment of intubation and one hour after.

Also known as: Noninvasive ventilation

PPNIV

Inhalatory O2 OTHER

Patients randomized to this group are submitted to inhalatory O2 using mask or nasal catheter. A blood gas is collected in the moment of intubation and one hour after.

Also known as: Oxygen therapy

O2I

Eligibility Criteria

• Age: 28 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 28 days and 15 years and who were intubated and remained under invasive mechanical ventilation for 48 hours, passed in the extubation test for, and who presented at least one of the following risk factors for respiratory distress post extubation:
• Invasive ventilation for at least 15 days
• Use of inotropics for more than 48 hours
• Endovenous continuous administration of sedative/analgesic drugs
• months old
• Mean Airway Pressure(Paw)\> 8,5; Inspired fraction of O2(FiO2)\> 0,4; Oxygenation index(IO)\> 4,5 immediately before extubation
• Cardiac or pulmonary chronic diseases
• Cardiac output
• Hipercapny: Arterial pressure of CO2 (PaCO2)\> 45 mmHg

You may not qualify if:

• Tracheostomized
• Accidental extubation
• Respiratory failure just after extubation, needing immediate reintubation
• Neuromuscular diseases
• Death
• Reintubated patients during its stay in PICU, that have already participated in this study

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Botucatu Medical School-UNESP

Botucatu, São Paulo, 18.618-970, Brazil

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation; Oxygen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Rafaelle F Batistella

  FMB - UNESP

  PRINCIPAL INVESTIGATOR

• José R Fioretto

  FMB-UNESP

  STUDY DIRECTOR

• Mário F Carpi

  FMB-UNESP

  STUDY CHAIR

Central Study Contacts

Rafaelle F Batistella, MD

CONTACT

+55-1438116300; rafaellefb@yahoo.com.br

José R Fioretto, MD, PhD

CONTACT

+55-1438116274; jrf@fmb.unesp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 15, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: February 2, 2011

Record last verified: 2011-02

Locations

BR (1)