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

Respiratory Failure Clinical Trial

— PTPPocc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040138
• Other study ID #: 6810
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Hospital Italiano de Buenos Aires
• Contact: Emilio Steinberg, RT
• Phone: +11 64977663
• Email: emilio.steinberg[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Weaning Failure

Intervention

Diagnostic Test:
• End expiratory occlusion maneuver
An end expiratory occlusion maneuver will be performed during pressure support ventilation in patients with prolonged weaning.

Locations

Country	Name	City	State
Argentina	Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"	Buenos Aires
Argentina	Hospital Británico	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Sanatorio Anchorena San Martín	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno, HOSPITAL BRITANICO DE BUENOS AIRES, Sanatorio Anchorena San Martin

Country where clinical trial is conducted

Argentina, 

References & Publications (17)

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Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway Occlusion Pressure	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	Esophageal Pressure Time product per breath (PTPESOF-br) and per minute (PTPESOF-min)	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