NCT05022082

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

July 29, 2021

Last Update Submit

November 30, 2022

Conditions

Keywords

chest physiotherapyaspirationinhaler drugschildnurse

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

EXPERIMENTAL

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

Inhaler drugs- Chest Physiotherapy- Aspiration group

OTHER

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

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.

Chest Physiotherapy- Aspiration- Inhaler drugs groupInhaler drugs- Chest Physiotherapy- Aspiration group

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Selmin Köse

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • SEVVAL UNAL, RN

    Istanbul University-Cerrahpaşa Cerrahpaşa School of Medicine

    PRINCIPAL INVESTIGATOR

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.

Locations