COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
UPECLIN HC FM Botucatu Unesp

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.

Condition or disease Intervention/treatment Phase
Extubation Failure Acute Respiratory Failure Post Extubation Other: Positive Pressure Noninvasive ventilation Other: Inhalatory O2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: PPNIV
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

Primary Outcome Measures :
  1. Prevention of reintubation [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. decrease of PICU and hospital mortality [ Time Frame: 28 days ]
  2. decrease of hospital and PICU length of stay [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977002

Layout table for location contacts
Contact: Rafaelle F Batistella, MD +55-1438116300
Contact: José R Fioretto, MD, PhD +55-1438116274

Layout table for location information
Botucatu Medical School-UNESP Recruiting
Botucatu, Sao Paulo, Brazil, 18.618-970
Contact: Rafaelle F Batistella, MD    +55-1438116300   
Contact: José R Fioretto, MD, PhD    +55-1438116274   
Principal Investigator: Rafaelle F Batistella, MD         
Sub-Investigator: José R Fioretto, PhD         
Sub-Investigator: Mário F Carpi, PhD         
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Layout table for investigator information
Principal Investigator: Rafaelle F Batistella FMB - UNESP
Study Director: José R Fioretto FMB-UNESP
Study Chair: Mário F Carpi FMB-UNESP
Layout table for additonal information
Responsible Party: Rafaelle Fernandes Batistella, UNESP- Botucatu Medical School Identifier: NCT00977002    
Other Study ID Numbers: upeclin/HC/FMB-Unesp-23
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: February 2011
Keywords provided by UPECLIN HC FM Botucatu Unesp:
noninvasive ventilation
Respiratory failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases