Condition category
Respiratory
Date applied
31/03/2010
Date assigned
09/04/2010
Last edited
09/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.usp.br/internacional/home.php?idioma=en

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

Publication citations

Additional files

Editorial Notes