Effects on the Expiratory Flow of AAD in a Critical Patient With IMV

August 9, 2024 updated by: julia estela, Parc Taulí Hospital Universitari

Effects on the Expiratoriy Flow of Assisted Autogen Drainage in a Critical Patient Wtih Invasive Mechanical Ventilation

One of the detrimental effects of invasive mechanical ventilation (IMV) is the alteration of the patient's mucociliary system that requires ventilatory support. The consequence of poor drainage of secretions, triggers secretion retention, atelectasis, and ventilator-associated pneumonia (VAP). Respiratory physiotherapy in the intubated patient facilitates the mobilization of retained and impacted secretions in the bronchial tree, decreasing resistance, improving lung compliance, and decreasing respiratory muscle work.

The main objective of the present study is to measure the expiratory flow generated by the application of the DAA technique in the intubated patient during, after, at the end of the technique and at two hours. As secondary objectives, it is proposed to observe whether the application of the DAA maneuver in the patient with IMV improves oxygenation, produces changes in respiratory mechanics, improves air entrapment, decreases exhaled volume post DAA and analyzes the tolerance of DAA in IMV-conscious patients The study will be performed on patients admitted to the Intensive Care Unit (ICU) of the Parc Taulí University Hospital in Sabadell with IMV requirements. The intervention will consist of performing a respiratory physiotherapy session as usual in the daily clinical practice of the ICU, specifically the technique of assisted autogenous drainage, before, during and after the Better CareTM platform will be used to continuously record the physiological variables. necessary for the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ventilated air blown into the bronchial shaft through the orotracheal tube (OT) causes ciliary dyskinesia by decreasing the rate of progression of secretions to the proximal pathways. The consequence of poor drainage of secretions is triggered by retention of secretions, atelectasis, and ventilator-associated pneumonia (VAP).

Humidification and heating of the air with devices added to the imv together with respiratory physiotherapy aim to prevent and / or treat respiratory complications. Respiratory physiotherapy in the intubated patient facilitates the mobilization of retained and impacted secretions in the bronchial tree, helping to decrease resistance, improve lung compliance, and decrease respiratory muscle work.

Respiratory physiotherapy consists of a variety of devices and manual techniques to improve secretion drainage, ventilatory mechanics, and gas exchange.

The lack of scientific evidence on the effect and efficacy of respiratory physiotherapy in the patient with imv makes it difficult for the physiotherapist to perform his task with certainty of the impact of the intervention on lung physiology. Published clinical guidelines recommend the application of respiratory physiotherapy techniques to critically ill patients, but the need to demonstrate their effects with well-designed, quality studies and conclusive results is emphasized.

The aim of this study is to analyze the effect of the technique developed by the Belgian physiotherapist Jean Chevaillier, called assisted autogen drainage (AAD), on the intubated patient.

AAD is defined as a secretion drainage technique where the goal is to create a sufficiently sustained, homogeneous and synchronous expiratory flow, increasing speed, and seeking an erosion effect on secretions at different levels of the bronchial tree.

In the review of the literature on respiratory physiotherapy in the area of critics and in patients with IMV, articles have been found with different techniques such as hyperinsufflation, techniques for increasing the expiratory flow such as squeezing or rib cage. compression ". These demonstrate the safety of the techniques but there is controversy over the effect of maneuvers on the drainage of secretions and ventilatory mechanics. The point of discussion in the discussion of the authors of the meta-analyzes and studies is the need for new studies evaluating the effectiveness of respiratory physiotherapy in lung mechanics.

Hypothesis Respiratory physiotherapy applied through assisted autogenous drainage increases respiratory flow in the airways and therefore may modify respiratory mechanics and promote drainage in ventilated patients.

Study Type

Observational

Enrollment (Actual)

23

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

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The subjects will be all patients over the age of 18 who are admitted to the ICU of the Parc Taulí University Hospital in Sabadell with IMV requirements

Description

Inclusion Criteria:

  • The subjects will be all patients over the age of 18 who are admitted to the ICU of the Parc Taulí University Hospital in Sabadell with IMV requirements
  • Subjects with hemodynamic stability; Higher mean blood pressure (PAM) 65 mmg, Heart rate (HR) less than 110 bpm and Oxygen saturation (SpO2) greater than 90% with or without norepinephrine <0.5 mcg / Kg / min.

Exclusion Criteria:

  • patients with platelet pressures (Pm) greater than 30 cmH2O and / or expiratory pressure at the end of expiration (PEEP) ≥ 10cmH2O
  • patients who carriers of thoracic drainage
  • patients with costal and / or sternal fractures
  • pneumothorax
  • pregnant women
  • Obesity (BMI> 35)
  • agitated patients with RASS greater than or equal to 3
  • patients with intracranial pressures greater than 20 cmH2O
  • dying.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the expiratory flow in the intubated patient
Time Frame: Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.
The following physiological variables will be obtained through the BC Link software using the services of the I3PT signal laboratory: final expiratory flow 25-75%(L/min)
Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To observe if the application of the AAD maneuver improves, produces changes in the respiratory mechanics; Compliance; Cst= Vt/Pplat-PEEP (ml/cmH2O)
Time Frame: Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.
The following physiological variables will be obtained through the BC Link software, re using the services of the I3PT signal laboratory.
Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.
To observe if the application of the AAD maneuver improves, produces changes in the respiratory mechanics; Resistance R=Ppeak-Pplat/flow ( kPa x L-1 x sg)
Time Frame: Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.
The following physiological variables will be obtained through the BC Link software, re using the services of the I3PT signal laboratory.
Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.

Collaborators and Investigators

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

Sponsor

Parc Taulí Hospital Universitari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019685

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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