Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure (PTPPocc)

March 7, 2024 updated by: EMILIO MARTIN STEINBERG, Hospital Italiano de Buenos Aires

Mechanical ventilation is essential in the management of patients in Intensive Care. The approach to patients with prolonged weaning is challenging.In this context, it is vital to implement "diaphragmatic protection" strategies, which consist of programming the level of ventilator assistance focused on sustaining the muscular effort within an objective range. The reference method for measuring inspiratory effort is the Pressure-Time Product (PTP) of the esophagus.

Recently, Bertoni et al. proposed the measurement of Occlusion Pressure as a non-invasive method, without the need to assess esophageal pressure, to estimate the magnitude of the effort and program assistance. Although it is a validated measurement for quantifying effort, it does not consider the duration of the effort performed by the patient, as well as the respiratory rate, two fundamental variables in terms of tolerance to the load. Therefore, the investigators propose the following study that will seek to validate the measurement of PTP in from the Occlusion Pressure, but considering inspiratory time and respiratory rate to obtain PTP per breath and per minute.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mechanical ventilation (MV) is an essential support in the management of patients in Intensive Care Units (ICU). According to international epidemiological studies, around 40% of patients admitted to ICU require ventilatory support.

International epidemiological data indicate that just over 55% of ICU patients are weaned from MV prematurely, and that approximately 20% experience difficult and prolonged weaning. In Argentina, our country, there are reports that this population amounts to 49.3%. One common denominator in the literature, international and national, regarding this section, is that such patients have more days of MV, ICU and hospital stay.

During prolonged weaning, monitoring of muscular effort becomes essential: both excessive and deficient efforts usually lead to diaphragmatic dysfunction. The former predisposes to fatigue, while the latter to atrophy. In this context, it is vital to implement "diaphragmatic protection" strategies, which consist of programming the level of assistance with a focus on muscular effort or muscular pressure (PMUS) to keep it within a target range.

The reference method for measuring inspiratory effort is the Pressure-Time Product of the esophagus (PTPESO), which involves the magnitude of PMUS measured through the change in esophageal pressure (PES) generated during inspiration, its duration, and respiratory rate (RR). For patients on partial ventilatory support, a PTP of 50 to 150 cmH2O/sec/min is recommended. Thus, PES becomes an everyday and reference tool for the management of patients with prolonged weaning from MV.

Recently, Bertoni et al. proposed measuring Occlusion Pressure (POCC) as a non-invasive method, i.e., without the need to evaluate PES, to estimate the magnitude of PMUS and program assistance in PSV. By means of a tele-expiratory occlusion maneuver of the airway, the maximum negative deflection of the signal during the patient's inspiration is quantified. This maneuver is called POCC. Then, through a simple multiplication by a constant, the value of PMUS in one cycle is obtained. Given the ease of measurement and its non-invasive nature, this technique has taken a leading role in the approach to patients during partial support at present.

Although the POCC is validated to quantify breathing effort, it has significant weaknesses. Some of these are that it only values the maximum deflection in an average of efforts, does not consider the time that the effort made by the patient lasts, nor the respiratory rate, two fundamental variables in terms of tolerance to the load (duration of contraction and frequency of repetition).

In this context, having a method that can estimate PTPESO non-invasively would be extremely useful to titrate the level of assistance in the framework of diaphragmatic protection strategies in patients with difficulties in being weaned from MV.

Therefore, the investigators propose the following study that will validate the measurement of PTPESO based on POCC, but considering the inspiratory time and respiratory rate to obtain PTP per breath and per minute. These variables will be called PTPPOCC-br and PTPPOCC-min, respectively.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"
        • Contact:
      • Buenos Aires, Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Sanatorio Anchorena San Martín
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years of age with prolonged weaning from mechanical ventilation, who are in the intensive care units of the following hospitals: Hospital Italiano, Hospital Británico, Centro de Educación Médica e Investigaciones Clínicas 'Norberto Quirno' and Sanatorio Anchorena de San Martín, will be included

Description

Inclusion Criteria:

  • Patients with mechanical ventilation, who failed 3 or more spontaneous breathing trials
  • Esophageal balloon placed
  • Who can trigger the ventilator
  • With hemodynamic stability
  • with P/F ratio above 150

Exclusion Criteria:

  • under 18 years old of age
  • pregnancy
  • do not resuscitate order or expected poor short term prognosis
  • refuse to sign the informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with prolonged weaning
Patients who have failed more than 3 spontaneous breathing trials, in pressure support ventilation, with hemodynamic and metabolic stability, and a regular and stable ventilatory pattern.
Diagnostic test: End expiratory occlusion maneuver
An end expiratory occlusion maneuver will be performed during pressure support ventilation in patients with prolonged weaning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway Occlusion Pressure
Time Frame: At the end of the study, estimated in July 2024
An inspiratory pressure will be set to obtain a muscular pressure value of 8 to 12 cmH2O. This phase will be called PSV100%. After 15 minutes, the level of assistance will be modified by 50%, up or down, according to the result of the randomization, and vice versa, always considering the initial value. Each of these phases will be called PSV150% and PSV50% respectively, and will last 15 minutes. During the last 3 minutes, 3 end-expiratory occlusion at a rate of 1 maneuver per minute will be performed, in order to obtain the airway Occlusion Pressure.
At the end of the study, estimated in July 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal Pressure Time product per breath (PTPESOF-br) and per minute (PTPESOF-min)
Time Frame: At the end of the study, estimated in July 2024
Both the PTPESOF - br and the PTPESOF - min will be obtained directly from FluxReview, which calculates it automatically. To do this, the operator must select the desired breaths and load the value of the chest compliance (CCW) as input. For the correct estimation of this parameter, the value derived from the estimated vital capacity of the patient will be used, a method described by Mauri et al. and used in similar studies. [16] Segments of the PES signal in which erratic values or with artifacts are present will be excluded from the analysis.
At the end of the study, estimated in July 2024

Collaborators and Investigators

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

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Sanatorio Anchorena San Martin
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
HOSPITAL BRITANICO DE BUENOS AIRES

Investigators

  • Principal Investigator: Emilio Steinberg, RT, Hospital Italiano

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)

October 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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