Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation
|ClinicalTrials.gov Identifier: NCT00977002|
Recruitment Status : Unknown
Verified February 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was: Recruiting
First Posted : September 15, 2009
Last Update Posted : February 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Extubation Failure Acute Respiratory Failure Post Extubation||Other: Positive Pressure Noninvasive ventilation Other: Inhalatory O2||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation: Randomized Controlled Trial|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2010|
Patient randomized to this group will be ventilated with Positive Pressure Noninvasive Ventilation post extubation
Other: Positive Pressure Noninvasive ventilation
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.
Other Name: Noninvasive ventilation
Active Comparator: O2I
Patient randomized to this group will be submitted to traditional oxygen therapy post extubation
Other: Inhalatory O2
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.
Other Name: Oxygen therapy
- Prevention of reintubation [ Time Frame: 48 hours ]
- decrease of PICU and hospital mortality [ Time Frame: 28 days ]
- decrease of hospital and PICU length of stay [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977002
|Contact: Rafaelle F Batistella, MDfirstname.lastname@example.org|
|Contact: José R Fioretto, MD, PhDemail@example.com|
|Botucatu Medical School-UNESP||Recruiting|
|Botucatu, Sao Paulo, Brazil, 18.618-970|
|Contact: Rafaelle F Batistella, MD +55-1438116300 firstname.lastname@example.org|
|Contact: José R Fioretto, MD, PhD +55-1438116274 email@example.com|
|Principal Investigator: Rafaelle F Batistella, MD|
|Sub-Investigator: José R Fioretto, PhD|
|Sub-Investigator: Mário F Carpi, PhD|
|Principal Investigator:||Rafaelle F Batistella||FMB - UNESP|
|Study Director:||José R Fioretto||FMB-UNESP|
|Study Chair:||Mário F Carpi||FMB-UNESP|