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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858844
Other study ID # CHEST COMPRESSION TECHNIQUE
Secondary ID
Status Completed
Phase N/A
First received May 9, 2013
Last updated May 16, 2013
Start date August 2012
Est. completion date November 2012

Study information

Verified date May 2013
Source Hospital Sirio-Libanes
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 24 Months
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
CHEST COMPRESSION TECHNIQUE (CCT)
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.

Locations

Country Name City State
Brazil Hospital do Mandaqui São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in clinical signs Variation in clinical signs of oxygenation and respiratory and cardiac frequency baseline, within one minute after and 10 min after CCT Yes
Secondary Changes in signs of respiratory distress Signs of respiratory distress baseline, within one minute after and 10 min after CCT Yes
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