Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00977002
First received: September 14, 2009
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Extubation Failure
Acute Respiratory Failure Post Extubation
Other: Positive Pressure Noninvasive ventilation
Other: Inhalatory O2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Prevention of reintubation [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • decrease of PICU and hospital mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • decrease of hospital and PICU length of stay [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977002

Contacts
Contact: Rafaelle F Batistella, MD +55-1438116300 rafaellefb@yahoo.com.br
Contact: José R Fioretto, MD, PhD +55-1438116274 jrf@fmb.unesp.br

Locations
Brazil
Botucatu Medical School-UNESP Recruiting
Botucatu, Sao Paulo, Brazil, 18.618-970
Contact: Rafaelle F Batistella, MD    +55-1438116300    rafaellefb@yahoo.com.br   
Contact: José R Fioretto, MD, PhD    +55-1438116274    jrf@fmb.unesp.br   
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
Investigators
Principal Investigator: Rafaelle F Batistella FMB - UNESP
Study Director: José R Fioretto FMB-UNESP
Study Chair: Mário F Carpi FMB-UNESP
  More Information

No publications provided

Responsible Party: Rafaelle Fernandes Batistella, UNESP- Botucatu Medical School
ClinicalTrials.gov Identifier: NCT00977002     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-23
Study First Received: September 14, 2009
Last Updated: February 1, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
noninvasive ventilation
extubation
Respiratory failure
reintubation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on April 16, 2014