- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01858844
Chest Compression Technique in Infants
May 16, 2013 updated by: Evelim Leal de Freitas Dantas Gomes, Hospital Sirio-Libanes
EVALUATION OF THE EFFECTS OF MANUAL CHEST COMPRESSION TECHNIQUE IN INFANTS WITH PULMONARY ATELECTASIS- Clinical CONTROLLED TRIAL
Evaluate the effect of chest manual compression technique (CCT) in the variables of oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are associated with atelectasis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 02401-400
- Hospital do Mandaqui
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Group A
- Infants (29 days to 24 months of age).
- After the legal representatives of the patients have read agreed and signed an informed consent
- Infants diagnosed with atelectasis by medical staff, with chest x-ray with opacification directors
- Respiratory disease
Group B (control group)
- Infants whose inpatient diagnosis has not been respiratory ailments that did not show any pain at the time of the evaluation.
For the control group followed the same evaluation criteria of group A.
Exclusion Criteria:
- Infants with respiratory disorders that don't have with atelectasis
- Infants who showed signs of irritability or intense crying at the time of evaluation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CHEST COMPRESSION TECHNIQUE 2
The CCT was held only once.
Prior to the start of data collection the patients were placed in supine position, with the slope of the headboard of the bed in 30 degrees for collection of signs of respiratory distress (runs), RR(respiratory rate)(timer for 1 minute); HR (heart rate) and SpO2(oxygen saturation) through pulse oximetry in infants without atelectasis.
|
The CCT was held with the placement of one of the hands were not engaged in.
The following has been applied a symmetric oblique direction, pressure from top to bottom on the half thorax rib cage so that it went according to the complacency of the ribcage.
This pressure was applied in the expiratory phase and held for 10 seconds, totaling 6 repetitions of the maneuver during 60 seconds.
The other hand held on the contralateral iliac crest to stabilize the patient.
The technique was held during 5 consecutive minutes with range of a respiratory incursion every 60 seconds.
Immediately after and 10 minutes after the end of the application of the technique, the data was measured again.
|
|
Experimental: CHEST COMPRESSION TECHNIQUE
The CCT was held only once.
Prior to the start of data collection the patients were placed in supine position, with the slope of the headboard of the bed in 30 degrees for collection of signs of respiratory distress (runs), RR (timer for 1 minute); HR and SpO2 through pulse oximetry in infants with atelectasis.
|
The CCT was held with the placement of one of the hands were not engaged in.
The following has been applied a symmetric oblique direction, pressure from top to bottom on the half thorax rib cage so that it went according to the complacency of the ribcage.
This pressure was applied in the expiratory phase and held for 10 seconds, totaling 6 repetitions of the maneuver during 60 seconds.
The other hand held on the contralateral iliac crest to stabilize the patient.
The technique was held during 5 consecutive minutes with range of a respiratory incursion every 60 seconds.
Immediately after and 10 minutes after the end of the application of the technique, the data was measured again.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in clinical signs
Time Frame: baseline, within one minute after and 10 min after CCT
|
Variation in clinical signs of oxygenation and respiratory and cardiac frequency
|
baseline, within one minute after and 10 min after CCT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in signs of respiratory distress
Time Frame: baseline, within one minute after and 10 min after CCT
|
Signs of respiratory distress
|
baseline, within one minute after and 10 min after CCT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evelim Leal de Freitas D Gomes, PhD, University of Nove de Julho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
May 9, 2013
First Submitted That Met QC Criteria
May 16, 2013
First Posted (Estimate)
May 21, 2013
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 16, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEST COMPRESSION TECHNIQUE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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