NCT06277817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

April 2, 2023

Last Update Submit

February 19, 2024

Conditions

Patient Involvement

Keywords

Expiratory rib cage compressioChest physiotherapyMechanical ventilationPercussion-VibrationIntensive care

Outcome Measures

Primary Outcomes (6)

  • The effect of percussion vibration on the amount of secretion

    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

    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

    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

    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

    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

    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

Study Arms (3)

expiratory rib cage compression group

EXPERIMENTAL

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

percussion vibration group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

expiratory rib cage compressionOTHER

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.

expiratory rib cage compression group
percussion vibrationOTHER

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.

percussion vibration group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunceli State Hospital

Tunceli, 62000, Turkey (Türkiye)

Location

Related Publications (1)

  • Olmaz D, Parlar Kilic S. Effects of Pre-Aspiration Chest Physiotherapy Techniques on Vital Signs, Blood Gas Values and Secretions in Mechanically Ventilated Patients. Nurs Crit Care. 2026 Jan;31(1):e70232. doi: 10.1111/nicc.70232.

    PMID: 41536156DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

April 2, 2023

First Posted

February 26, 2024

Study Start

May 19, 2021

Primary Completion

June 25, 2021

Study Completion

October 24, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU(1)