Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05022082
Other study ID # BIRUNIUNIVERSITY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date November 30, 2022

Study information

Verified date November 2022
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 30, 2022
Est. primary completion date November 4, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 6 Years
Eligibility Inclusion Criteria: - Hospitalized patients at Cerrahpasa 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Selmin Köse Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Selmin Kose

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other 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.
Other 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.
Other 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.
Primary 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 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.
See also
  Status Clinical Trial Phase
Withdrawn NCT03376204 - Pain Mechanisms in Patients With Bronchiectasis
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT05246098 - REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI
Completed NCT04467190 - Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions
Not yet recruiting NCT05374148 - Respiratory Health Problems Among Workers in Ferrosilicon Alloys Industry in Aswan-Eygpt.
Recruiting NCT04502368 - Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients
Recruiting NCT05775952 - Airway Remodeling and Rhinovirus in Asthmatics
Active, not recruiting NCT02681848 - What Are the Effects of Varenicline Compared With Nicotine Replacement Therapy on Long Term Smoking Cessation and Clinically Important Outcomes?
Recruiting NCT06002685 - Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention N/A
Enrolling by invitation NCT03319446 - Collection of Anonymized Samples N/A
Recruiting NCT04287959 - SWISH Trial (Strategies for Weaning Infants on Supportive High Flow) N/A
Completed NCT05017727 - Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term
Completed NCT04607330 - Protein Top-up Acceptability Study for Patients With Increased Protein Needs N/A
Completed NCT03334916 - A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients Phase 4
Completed NCT04649736 - Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients N/A
Completed NCT03661801 - Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions
Enrolling by invitation NCT03322254 - How Respiratory Pathogens Panel Results Affect Patients' Plan of Care
Recruiting NCT03937583 - Screening for Cancer in Patients With Unprovoked VTE Phase 4
Not yet recruiting NCT06026163 - Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress Phase 2/Phase 3
Completed NCT04581096 - Mapping COVID-19 Spread in a Tertiary Hospital

External Links