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The Efficiency of Chest Physiotherapy Applied in a Different Order

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Chest Physiotherapy- Aspiration- Inhaler drugs group
Sponsored by
Selmin Kose
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Disease focused on measuring chest physiotherapy, aspiration, inhaler drugs, child, nurse

Eligibility Criteria

1 Month - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Selmin Köse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Chest Physiotherapy- Aspiration- Inhaler drugs group

Inhaler drugs- Chest Physiotherapy- Aspiration group

Arm Description

The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.

The 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physiological Parameter Assessment Form Showing The Change In SPO2%
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 SPO2% in the clinic. The researcher will be assessed the SPO2% 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 30 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 SPO2% will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.

Full Information

First Posted
July 29, 2021
Last Updated
November 30, 2022
Sponsor
Selmin Kose
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1. Study Identification

Unique Protocol Identification Number
NCT05022082
Brief Title
The Efficiency of Chest Physiotherapy Applied in a Different Order
Official Title
Comparison of the Efficiency of Chest Physiotherapy Applied in a Different Order in Pediatric Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Selmin Kose

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
42 children who complied with the inclusion criteria will be included in the study. The mother or father of the children hospitalized in the pediatric intensive care unit of the hospital where the study is conducted will be given information about the study and asked to sign the "Informed Voluntary Consent Form". After the family's approval, they will be asked to fill out the "Parent Introductory Information Form". The randomization method will be used to create the control group and the study group. Children to be included in the study will be placed in the groups with the randomized controlled method with 21 children in each group. The randomization of the study will be made with the online program available at the URL address https://www.randomizer.org/. Before entering the sample size in the program, lots will be drawn, and the 1st set will be assigned to the control group, and the 2nd set will be assigned to the study group. In order to determine in which group the children involved in the study will be placed, numbers from 1 to 42 will be entered into the program without repetition. Children that will constitute the study group through the program will be randomly distributed into 2 groups. The 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. The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy. The "Patient Data Collection Forms" of both groups will be filled out. Chest physiotherapy will follow the "Tapotement and Vibration Application Procedure," and aspiration will follow the "Nasopharyngeal and Oropharyngeal Aspiration Application Procedure". The "Patient Physiologic Parameter Assessment Form" information will be recorded before the application and 30 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 (Puntillo et al. 2001). Based on this information, vital findings will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes. Obtained data will be evaluated using necessary statistical tests in the computer environment. Evaluation methods will be selected considering if data is distributed homogenously. If it has a homogenous distribution, parametric tests will be used. If it does not have a homogenous distribution, non-parametric methods will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
chest physiotherapy, aspiration, inhaler drugs, child, nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Masking Description
The researchers (are nurses) have roles of care provider and also investigator.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest Physiotherapy- Aspiration- Inhaler drugs group
Arm Type
Experimental
Arm Description
The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.
Arm Title
Inhaler drugs- Chest Physiotherapy- Aspiration group
Arm Type
Other
Arm Description
The 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
Intervention Type
Other
Intervention Name(s)
Chest Physiotherapy- Aspiration- Inhaler drugs group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physiological Parameter Assessment Form Showing The Change In Heart Rate
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Physiological Parameter Assessment Form Showing The Change In SPO2%
Description
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 SPO2% in the clinic. The researcher will be assessed the SPO2% 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 30 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 SPO2% will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
Time Frame
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 Pre-specified Outcome Measures:
Title
Physiological Parameter Assessment Form Showing The Change In Respiration rate/min
Description
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 respiration rate/min in the clinic. The researcher will be assessed the respiration rate/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 30 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 respiration rate/min will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
Time Frame
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.
Title
Physiological Parameter Assessment Form Showing The Change In Blood pressure (mmHg)
Description
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 respiration blood pressure (mmHg) in the clinic. The researcher will be assessed the blood pressure (mmHg) 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 30 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 blood pressure (mmHg) will be recorded in the "Patient Physiologic Parameter Assessment Form" after 30 minutes.
Time Frame
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.
Title
Physiologic Parameter Assessment Form Showing The Change In Blood gas (mmHg)
Description
In the clinic, although the time varies depending on the physician's request, the blood gas will driven twice a day routinely.
Time Frame
The blood gas will driven twice a day routinely.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEVVAL UNAL, RN
Organizational Affiliation
Istanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selmin Köse
City
İstanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.

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The Efficiency of Chest Physiotherapy Applied in a Different Order

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