NCT01858844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

May 9, 2013

Last Update Submit

May 16, 2013

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in signs of respiratory distress

    baseline, within one minute after and 10 min after CCT

Study Arms (2)

CHEST COMPRESSION TECHNIQUE 2

ACTIVE COMPARATOR

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.

Other: CHEST COMPRESSION TECHNIQUE (CCT)

CHEST COMPRESSION TECHNIQUE

EXPERIMENTAL

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.

Other: CHEST COMPRESSION TECHNIQUE (CCT)

Interventions

CHEST COMPRESSION TECHNIQUE (CCT)OTHER

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.

CHEST COMPRESSION TECHNIQUECHEST COMPRESSION TECHNIQUE 2

Eligibility Criteria

Age29 Days - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Infants with respiratory disorders that don't have with atelectasis
  • Infants who showed signs of irritability or intense crying at the time of evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Mandaqui

São Paulo, São Paulo, 02401-400, Brazil

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Evelim Leal de Freitas D Gomes, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 21, 2013

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

BR(1)