The Efficiency of Chest Physiotherapy Applied in a Different Order
Comparison of the Efficiency of Chest Physiotherapy Applied in a Different Order in Pediatric Intensive Care Patients
1 other identifier
interventional
42
1 country
1
Brief Summary
This study intends to compare the impact of chest physiotherapy applied with two different methods on physiologic parameters in children hospitalized in the intensive care unit. In the intensive care unit where the study was conducted, the patients who have a respiratory disorder and receive supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask are first administered an inhaler drug therapy placed in the physician's order. It is followed by chest physiotherapy and then oropharyngeal and nasopharyngeal aspiration. However, in practice rendered by the researcher, it is suggested that when chest physiotherapy and aspiration are administered in the first place and then followed by an inhaler drug therapy, it might have a more positive impact on the patient's physiologic parameters. For this reason, it is intended to compare the efficiency of chest physiotherapy applied in a different order.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 1, 2022
November 1, 2022
10 months
July 29, 2021
November 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physiological Parameter Assessment Form Showing The Change In Heart Rate
Chest physiotherapy applied in a different order in pediatric intensive care patients causes a difference in the patient's physiologic parameters.This form prepared by the researcher includes recording pulse rate/min in the clinic. The researcher will be assessed the pulse/min at least four times before and after the chest physiotherapy in a day. The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 20 minutes after the application. It is known that the stress hormones epinephrine and norepinephrine half-life is 1-3 minutes, and it is believed that after a stressful invasive intervention, the release of stress hormones increases but turns back to their normal levels in 15-20 minutes. Based on this information, the pulse will be recorded in the "Patient Physiologic Parameter Assessment Form" after 20 minutes.
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
Secondary Outcomes (1)
Physiological Parameter Assessment Form Showing The Change In SPO2%
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
Other Outcomes (3)
Physiological Parameter Assessment Form Showing The Change In Respiration rate/min
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
Physiological Parameter Assessment Form Showing The Change In Blood pressure (mmHg)
This procedure will be applied to each patient for 30 minutes 4 times a day. It will be applied for at least 2 days and until the patient is discharged.
Physiologic Parameter Assessment Form Showing The Change In Blood gas (mmHg)
The blood gas will driven twice a day routinely.
Study Arms (2)
Chest Physiotherapy- Aspiration- Inhaler drugs group
EXPERIMENTALThe study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.
Inhaler drugs- Chest Physiotherapy- Aspiration group
OTHERThe control group (n=21) will be administered the inhaler drug routinely administered in the intensive care unit where the study is conducted and then receive chest physiotherapy (tapotement or vibration), then nasopharyngeal and oropharyngeal aspiration
Interventions
In the intensive care unit where the study was conducted, the patients who have a respiratory disorder and receive supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask are first administered an inhaler drug therapy placed in the physician's order. It is followed by chest physiotherapy and then oropharyngeal and nasopharyngeal aspiration. However, in practice rendered by the researcher, it is suggested that when chest physiotherapy and aspiration are administered in the first place and then followed by an inhaler drug therapy, it might have a more positive impact on the patient's physiologic parameters.
Eligibility Criteria
You may qualify if:
- Hospitalized patients at Cerrahpaşa Faculty of Medicine Pediatric Intensive Care Unit 1,
- Aged between 1 months-6 years,
- Having been in intensive care for at least two days,
- Concious pediatric patient,
- Receiving supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask,
- Being administered chest physiotherapy (Tapotement or Vibration),
- Being administered oropharyngeal and nasopharyngeal aspiration,
- Inhaler drug therapy included in the patient's order,
- Parents, volunteering for the study.
You may not qualify if:
- Parents not volunteering for the study,
- Patients younger than 1-month or older than 6-years old,
- Not receiving supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask
- Not being administered oropharyngeal and nasopharyngeal aspiration,
- Inhaler drug therapy is not included in the physician's order.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Selmin Koselead
Study Sites (1)
Selmin Köse
Istanbul, 34010, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SEVVAL UNAL, RN
Istanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Masking Details
- The researchers (are nurses) have roles of care provider and also investigator.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 26, 2021
Study Start
January 20, 2022
Primary Completion
November 4, 2022
Study Completion
November 30, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share
Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.