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Chest Compression Technique in Infants

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CHEST COMPRESSION TECHNIQUE (CCT)
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis

Eligibility Criteria

29 Days - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital do Mandaqui

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHEST COMPRESSION TECHNIQUE 2

CHEST COMPRESSION TECHNIQUE

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Changes in clinical signs
Variation in clinical signs of oxygenation and respiratory and cardiac frequency

Secondary Outcome Measures

Changes in signs of respiratory distress
Signs of respiratory distress

Full Information

First Posted
May 9, 2013
Last Updated
May 16, 2013
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT01858844
Brief Title
Chest Compression Technique in Infants
Official Title
EVALUATION OF THE EFFECTS OF MANUAL CHEST COMPRESSION TECHNIQUE IN INFANTS WITH PULMONARY ATELECTASIS- Clinical CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHEST COMPRESSION TECHNIQUE 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CHEST COMPRESSION TECHNIQUE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CHEST COMPRESSION TECHNIQUE (CCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in clinical signs
Description
Variation in clinical signs of oxygenation and respiratory and cardiac frequency
Time Frame
baseline, within one minute after and 10 min after CCT
Secondary Outcome Measure Information:
Title
Changes in signs of respiratory distress
Description
Signs of respiratory distress
Time Frame
baseline, within one minute after and 10 min after CCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelim Leal de Freitas D Gomes, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Mandaqui
City
São Paulo
State/Province
SP
ZIP/Postal Code
02401-400
Country
Brazil

12. IPD Sharing Statement

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Chest Compression Technique in Infants

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