Contact information
Type
Scientific
Primary contact
Dr Flávia Foronda
ORCID ID
Contact details
Rua do Chá
21
São Paulo
05688-080
Brazil
+55 11 37550945
flikrepel@foronda.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Daily evaluation and spontaneous respiratory test for shorter times in paediatric mechanical ventilation: a randomised controlled trial
Acronym
Study hypothesis
In this study, we tested the hypothesis of the combination of a daily evaluation and application of a spontaneous respiratory test in children, being able to shorten the required mechanical ventilation time, compared to weaning based on our standard of care.
Ethics approval
1. Comitê de Ética em Pesquisa do Hospital Universitário da Universidade de São Paulo approved on the 19th January 2007 (ref: CEP-HU/USP:710/06 - SISNEP CAAE: 0819.0.015.000-06)
2. Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq da Diretoria Clinica do Hospital das Clínicas e da Faculdade de Medicina da Universidade de São Paulo approved on the 23rd November 2006 (ref: 992/06)
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute respiratory insufficiency
Intervention
All patients from the test group were submitted to a daily evaluation performed every morning by an intern not involved with the decision of extubation. This evaluation considered the following information: absence of new infiltrates according to the thoracic x-ray, fraction of inspired oxygen (FiO2) less than or equal to 50%, positive end expiratory pressure (PEEP) less than or equal to 8 cm H2O, inspiratory pressure (Pinsp) less than 25 cm H2O, presence of respiratory drive, absence of neuromuscular blocker in the last 24 hours, correction of hydrolytic changes (calcium, phosphorus, magnesium, potassium), haemodynamic stability (use of sodium nitroprusside, dopamine and dobutamine up to 10 µg/Kg/min), no continuous sedation, and haemoglobin greater than or equal to 8 g/dL. This evaluation was performed daily until the patient was extubated.
Patients in the test group who fulfilled the daily evaluation were submitted to a spontaneous respiratory test with PEEP 5 cm H2O, pressure support of 10 cm H2O and FiO2 used before the test, for a period of two hours. The test was interrupted whenever patients presented any of the criteria characteristics of a faulty test: increase in respiratory frequency 20% above the initial value, signs of increased respiratory work (use of accessory muscles and paradoxical respiration), cardiac frequency 20% above the initial value, changes in consciousness level (restlessness or sleepiness), arterial pressure less than 5th percentile for patient's age, saturation less than 90%, gas carbonic arterial pressure (PaCO2) greater than 50 mmHg or an increase above 10 mmHg in 1 hour in chronic patients.
Right before the test and in the first hour of the test, two arterial blood gas analysis were collected. If the patient did not meet any of the criteria of a faulty test, extubation was performed. Otherwise, mechanical ventilation was re-established according to the previous parameters and the test repeated in 24 hours.
The respiratory test was not performed in the control group. Weaning was performed according to the routine procedure.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Duration of mechanical ventilation compared to weaning, measured at time of extubation
Secondary outcome measures
Measured 48 hours after extubation:
1. Faulty extubation rate
2. Need for post-extubation non-invasive mechanical ventilation
Overall trial start date
01/07/2007
Overall trial end date
01/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged between 28 days and 15 years old, either sex
2. Admitted to the Hospital das Clínicas da Universidade de São Paulo - HCFMUSP and Hospital Universitário, Brazil, between July 2007 and July 2009
3. Underwent mechanical ventilation for a period over 24 hours
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
294 children (139 = control group; 155 = test group)
Participant exclusion criteria
1. Younger than 28 days
2. Intubation due to upper airway obstruction (UAO)
3. Lack of consent-form
4. Presence of hernia or diaphragmatic paralysis
5. Chronic use of mechanical ventilation
6. Congenital cyanogenic cardiopathy
7. Primary pulmonary hypertension
8. Neuromuscular disease
9. Tracheostomy
Patients were included in the study only once and only the first intubation of those patients requiring a re-intubation was considered in the analysis.
Recruitment start date
01/07/2007
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua do Chá, 21
São Paulo
05688-080
Brazil
Sponsor information
Organisation
University of São Paulo (Brazil)
Sponsor details
Pediatric Department
Hospital das Clínicas
Av. Dr. Enéas de Carvalho Aguiar
647
São Paulo
05403-000
Brazil
+55 11 30698594
flikrepel@foronda.com.br
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary