Clinical trial NCT05022082: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
Keywords: chest physiotherapy
aspiration
inhaler drugs
child
nurse
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Physiological Parameter Assessment Form Showing The Change In Heart Rate
timeFrame: 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:
measure: Physiological Parameter Assessment Form Showing The Change In SPO2%
timeFrame: 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:
measure: Physiological Parameter Assessment Form Showing The Change In Respiration rate/min
timeFrame: 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.
measure: Physiological Parameter Assessment Form Showing The Change In Blood pressure (mmHg)
timeFrame: 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.
measure: Physiologic Parameter Assessment Form Showing The Change In Blood gas (mmHg)
timeFrame: The blood gas will driven twice a day routinely.
Locations:
city: İstanbul
country: Turkey
facility: Selmin Köse
Study officials:
affiliation: Istanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
name: SEVVAL UNAL, RN
role: PRINCIPAL_INVESTIGATOR
References: