AtelectasisNCT01858844
Chest Compression Technique in Infants
A study testing CHEST COMPRESSION TECHNIQUE (CCT) in people with Atelectasis, run by Hospital Sirio-Libanes at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 29 days to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- CHEST COMPRESSION TECHNIQUE (CCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Infants with respiratory disorders that don't have with atelectasis
- Infants who showed signs of irritability or intense crying at the time of evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atelectasis
- Being tested
- CHEST COMPRESSION TECHNIQUE (CCT)
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: CHEST COMPRESSION TECHNIQUE (CCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical signs
Variation in clinical signs of oxygenation and respiratory and cardiac frequency
Measured: baseline, within one minute after and 10 min after CCT
Secondary outcomes (1)
Changes in signs of respiratory distress
Signs of respiratory distress
Measured: baseline, within one minute after and 10 min after CCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelim Leal de Freitas Dantas Gomes, Hospital Sirio-Libanes
- Investigators
- Evelim Leal de Freitas D Gomes, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858844
- Sponsor's protocol ID
- CHEST COMPRESSION TECHNIQUE
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTS OF MANUAL CHEST COMPRESSION TECHNIQUE IN INFANTS WITH PULMONARY ATELECTASIS- Clinical CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01858844
- Acronym / sponsor ID
- CHEST COMPRESSION TECHNIQUE
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHEST COMPRESSION TECHNIQUE 2 | Active comparator | Other: CHEST COMPRESSION TECHNIQUE (CCT)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. |
| CHEST COMPRESSION TECHNIQUE | Experimental | Other: CHEST COMPRESSION TECHNIQUE (CCT)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. |
Who may qualify
- Ages
- 29 days to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Infants with respiratory disorders that don't have with atelectasis
- Infants who showed signs of irritability or intense crying at the time of evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CHEST COMPRESSION TECHNIQUE, CHEST COMPRESSION TECHNIQUE 2 |
Primary outcome
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
1 secondary outcome
Changes in signs of respiratory distress
Time frame: baseline, within one minute after and 10 min after CCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelim Leal de Freitas D Gomes, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHEST COMPRESSION TECHNIQUE (CCT) in people with Atelectasis, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clinical signs (time frame: baseline, within one minute after and 10 min after CCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.