The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics

February 19, 2024 updated by: Serap Parlar Kılıç, Inonu University

The Effect of Chest Physiotherapy Techniques Applied Before Aspiration on Vital Signs, Blood Gas Values and Secretion Amount in Patients on Mechanical Ventilation Support

Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was carried out to determine the effect of chest physiotherapy techniques applied before aspiration on the vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.This randomized, controlled and experimental study was conducted between May 2021 and October 2022 in Tunceli State Hospital intensive care units with patients on mechanical ventilation support. The study was completed with a total of 78 patients, including the percussion vibration group (n=26), the expiratory rib cage compression group (n=26), and the control group (n=26). Data were collected with the "Patient Identification Form", "Vital Signs Recording Form", "Blood Gas Values Recording Form" and "Secretion Amount Recording Form". Two aspirations were performed in each of the three groups with an interval of three hours. Three hours after the first aspiration, chest physiotherapy techniques were applied to the two experimental groups, but not to the control group. A second aspiration was then performed. Vital signs and blood gases were measured before and after both aspiration procedures, and the amount of secretion collected during the two aspiration procedures was weighed.In the comparison between groups according to time; Statistically significant changes were found in heart rate during the first aspiration period, and diastolic blood pressure and respiratory rate during the second aspiration period (p<0.05). In the independent comparison between groups; statistically significant difference was found in diastolic blood pressure, respiratory rate and peripheral SpO2 values (p<0.05). In group comparisons; while the averages of secretion weight and amount did not show a significant change in all three groups (p>0.05), it was found that it tended to increase in the percussion-vibration and expiratory rib cage compression groups, while it tended to decrease in the control group.In this study, it was concluded that chest physiotherapy techniques had a beneficial effect on some vital signs in patients on mechanical ventilation support, did not make any difference in other parameters. Further studies are needed to determine the positive effects of these techniques on vital signs, blood gases and secretion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tunceli, Turkey, 62000
        • Tunceli State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and older
  • Intubated in the intensive care unit for more than 48 hours
  • Followed in synchronized intermittent mechanical ventilation (SIMV) mode
  • with arterial catheter
  • with hemodynamic stability
  • PEEP <10
  • Patients with Glasgow Coma Scale >3 were included.

Exclusion Criteria:

  • Rib fracture, chest trauma
  • with pneumothorax
  • with hemoptysis
  • with increased intracranial pressure
  • Having a history of spine surgery
  • with chest drainage tube
  • Those with skin infection and subcutaneous emphysema in the back and chest area
  • The mechanical ventilation setting to be changed during the study
  • with life-threatening cardiac arrhythmia
  • pregnant
  • Obese (Body Mass Index >30)
  • Patients who had to be aspirated outside of the specified periods during the study were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: expiratory rib cage compression group
Expiratory rib cage compression procedure phase; Three hours after the first aspiration data were obtained, before the second aspiration, expiratory rib cage compression was applied for 5 minutes in the right lateral and left lateral positions, applying to both lungs, with the most affected lung area first. Before and after the procedure, vital signs, blood gas parameters were measured and the amount of secretion collected during the aspiration process was weighed.
Other: expiratory rib cage compression
Expiratory rib cage compression: The hands are placed on the lower third of the rib cage. During expiration, the end and sides of the patients' rib cage are gradually compressed with the hands.At the end of expiration, compression is released from the thorax to allow patients to take a free inspiration. After each compression, the patient is allowed to perform 3 breathing cycles.Expiratory rib cage compression is applied for 5 minutes.
Experimental: percussion vibration group
Percussion, vibration process stage; Three hours after the first aspiration data were obtained, before the second aspiration, percussion and vibration were applied 3-5 times to each area, starting from the right and left lower lobes, in the right lateral and left lateral positions, with the most affected lung area being applied to both lungs first. Vital signs, blood gas parameters were measured before and after the procedure, and the amount of secretion collected during the aspiration process was weighed.
Other: percussion vibration
Percussion :Percussion is performed 3-5 times on each area from a height of approximately 10 cm with the domed hand. . It starts from the right and left lower lobes and goes up.Vibration:The hand is firmly/strongly placed on the application area. The arm and shoulder are stretched and the fingers are gently vibrated or shaken gently. While the patient is exhaling, vibration is performed 3-5 times in each area, starting from the right and left lower lobes.
No Intervention: control group
Control group phase; In this group, vital signs, blood gases, and secretion amount were recorded at the same time as the experimental groups, without any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effect of percussion vibration on the amount of secretion
Time Frame: about a year
Pecussion vibration was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
about a year
Effect of expiratory rib cage compression on the amount of secretion
Time Frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
about a year
Effect of percussion vibration on blood gas parameters
Time Frame: about a year
Percussion vibration was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying percussion vibration
about a year
Effect of expiratory rib cage compression on blood gas parameters
Time Frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying expiratory rib cage compression.
about a year
Perküsyon vibrasyonun yaşam bulgularına etkisi
Time Frame: about a year
Percussion vibration was applied before endotracheal aspiration. Vital signs measurements of systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying percussion vibration.
about a year
Effect of expiratory rib cage compression on vital signs
Time Frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration. Vital signs measurements such as systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying expiratory rib cage compression.
about a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/1916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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