Clinical trial NCT00977002: Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation
Official title: Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extubation Failure
Acute Respiratory Failure Post Extubation
Keywords: noninvasive ventilation
extubation
Respiratory failure
reintubation
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2009-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Prospective, randomized and controlled study at the PICU - University Hospital, Botucatu Medical School-UNESP. Patients elegibled are exposed to extubation test. If passed they are randomized in two groups: 1) post-extubation PPNIV (PPNIV, n=50), and 2) Inhalatory oxygen therapy by nasal catheter or facial mask (O2I, n=50). Patients are observed for 48 hours, being considered extubation failure if they need reintubation. Arterial blood gas is obtained at the day or programed extubation and one hour after extubation.

Nasal prongs and facial or nasal masks are used in accordance with child age. All patients from this group are kept in PPNIV for a 12 hours at least. Feeding, if released, is done by gastric probe.

In O2IG, patients use facial mask or nasal catheter after extubation. Both groups are submitted to physiotherapy and nurse care as the PICU routine Follow up: Variables: age, gender, disease and comorbidities, intubation cause , time intubated and invasive ventilation use, PRISM score at the moment of admission, risk factors to respiratory distress post extubation, Comfort scale just before extubation, use of sedatives (time and mean dose)during invasive ventilation. At randomization and one hour later: vital signs, arterial blood gas. Patients are followed for 48 hour to evaluate reintubation and then for other complications, death and length of stay in PICU and hospital.

Eligibility criteria: Inclusion Criteria:

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:

1. Invasive ventilation for at least 15 days
2. Use of inotropics for more than 48 hours
3. Endovenous continuous administration of sedative/analgesic drugs
4. 1-3 months old
5. Mean Airway Pressure(Paw)\> 8,5; Inspired fraction of O2(FiO2)\> 0,4; Oxygenation index(IO)\> 4,5 immediately before extubation
6. Cardiac or pulmonary chronic diseases
7. Cardiac output
8. Hipercapny: Arterial pressure of CO2 (PaCO2)\> 45 mmHg

Exclusion Criteria:

1. Tracheostomized
2. Accidental extubation
3. Respiratory failure just after extubation, needing immediate reintubation
4. Neuromuscular diseases
5. Death
6. PPNIV exclusion: coma or disability to protect airway, not tolerated, hemodynamic instability, shock, cardiac disritmy, facial or intracranial traumatic injury or surgery that preclude use of mask, abdominal distension, nausea or vomiting, gastric or esophagic recent surgery, gastrointestinal hemorrhagy in activity, not drained pneumothorax.
7. Reintubated patients during its stay in PICU, that have already participated in this study

Primary outcomes:
measure: Prevention of reintubation
timeFrame: 48 hours
Secondary outcomes:
measure: decrease of PICU and hospital mortality
timeFrame: 28 days
measure: decrease of hospital and PICU length of stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Botucatu Medical School-UNESP
state: Sao Paulo
Study officials:
affiliation: FMB - UNESP
name: Rafaelle F Batistella
role: PRINCIPAL_INVESTIGATOR
affiliation: FMB-UNESP
name: José R Fioretto
role: STUDY_DIRECTOR
affiliation: FMB-UNESP
name: Mário F Carpi
role: STUDY_CHAIR
References: