Comparing the effects of Intermittent Positive Pressure Ventilation and Spontaneous Ventilation on Cardiorespiratory Parameters of Pediatric Patients less than 1 year old.
Aims:
We aimed to compare the effects of Intermittent Positive Pressure Ventilation and Spontaneous Ventilation on cardiorespiratory parameters of pediatric patients less than 1 year old, undergoing Angiography under general anesthesia.
Inclusion and exclusion key criteria:
Inclusion:Age below 1 year ; Candidate for elective cardiac angiography ; ASA class II.
Exclusion:
Refuse to accept informed consent ; History of co-existing respiratory or neural anomaly ; Having received sedatives prior to cath admission ; History of patient or mother drug abuse ; Body weight below 3kg ; birth weight below 2.5kg.
Population Studied:
Pediatric patients, under 1 year, candidate for cardiac angiography.
Sample Size:
60 patients.
Intervention:
The candidates will be randomly assigned into two groups of Intermittent Positive Pressure Ventilation and Spontaneous ventilation. Induction with ketamine, intubation and maintenance of anesthesia with sevoflurane gas were performed.
The first group: had respiratory support via Intermittent Positive Pressure Ventilation.
The second group: breathe spontaneously.
Primary Outcomes:
Arterial oxygen saturation, arterial carbon dioxide tension, pulmonary to systemic arterial blood pressure and left atrial pressure will be evaluated during the procedure and then analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012920793N2
Registration date:2015-12-18, 1394/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-18, 1394/09/27
Registrant information
Name
Behrang Nooralishahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 1030
Email address
b-nooralishahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Intermittent Positive Pressure Ventilation and Spontaneous Ventilation on Cardiorespiratory Parameters of Pediatric Patients less than 1 year old.
Public title
Comparing the effects of Intermittent Positive Pressure Ventilation and Spontaneous Ventilation on Cardiorespiratory Parameters of Pediatric Patients less than 1 year old, undergoing Angiography under general anesthesia.
in Children’s Medical Center, 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age below 1 year ; Candidate for elective cardiac angiography ; ASA class II
Exclusion Criteria:
Refuse to accept informed consent ; History of co-existing respiratory or neural anomaly ; Having received sedatives prior to cath admission ; History of patient or mother drug abuse ; Body weight below 3kg ; birth weight below 2.5kg.
Age
From 14 days old to 12 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Comittee of ethics.
Street address
Tehran University of Medical Sciences, faculty of medicine.