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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease
• Intervention / Treatment: Other: Chest Physiotherapy- Aspiration- Inhaler drugs group

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Selmin Köse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chest Physiotherapy- Aspiration- Inhaler drugs group; The study group (n=21) will first receive chest physiotherapy (tapotement or vibration) and aspiration, followed by inhaler drug therapy.	Other: Chest Physiotherapy- Aspiration- Inhaler drugs group; 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.
Other: Inhaler drugs- Chest Physiotherapy- Aspiration group; 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	Other: Chest Physiotherapy- Aspiration- Inhaler drugs group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Parameter Assessment Form Showing The Change In Respiration rate/min	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.	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)	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.	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)	In the clinic, although the time varies depending on the physician's request, the blood gas will driven twice a day routinely.	The blood gas will driven twice a day routinely.

Collaborators and Investigators

• Sponsor: Selmin Kose
• Investigators: Principal Investigator: SEVVAL UNAL, RN, İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: child; nurse; chest physiotherapy; aspiration; inhaler drugs
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: BIRUNIUNIVERSITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No