xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040138</url>
    </required_header>
    <id_info>
      <org_study_id>6810</org_study_id>
      <nct_id>NCT06040138</nct_id>
    </id_info>
    <brief_title>Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure</brief_title>
    <acronym>PTPPocc</acronym>
    <official_title>Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Italiano de Buenos Aires</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>HOSPITAL BRITANICO DE BUENOS AIRES</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sanatorio Anchorena San Martin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital Italiano de Buenos Aires</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mechanical ventilation is essential in the management of patients in Intensive Care. The&#xD;
        approach to patients with prolonged weaning is challenging.In this context, it is vital to&#xD;
        implement &quot;diaphragmatic protection&quot; strategies, which consist of programming the level of&#xD;
        ventilator assistance focused on sustaining the muscular effort within an objective range.&#xD;
        The reference method for measuring inspiratory effort is the Pressure-Time Product (PTP) of&#xD;
        the esophagus.&#xD;
  &#xD;
        Recently, Bertoni et al. proposed the measurement of Occlusion Pressure as a non-invasive&#xD;
        method, without the need to assess esophageal pressure, to estimate the magnitude of the&#xD;
        effort and program assistance. Although it is a validated measurement for quantifying effort,&#xD;
        it does not consider the duration of the effort performed by the patient, as well as the&#xD;
        respiratory rate, two fundamental variables in terms of tolerance to the load. Therefore, the&#xD;
        investigators propose the following study that will seek to validate the measurement of PTP&#xD;
        in from the Occlusion Pressure, but considering inspiratory time and respiratory rate to&#xD;
        obtain PTP per breath and per minute.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mechanical ventilation (MV) is an essential support in the management of patients in&#xD;
        Intensive Care Units (ICU). According to international epidemiological studies, around 40% of&#xD;
        patients admitted to ICU require ventilatory support.&#xD;
  &#xD;
        International epidemiological data indicate that just over 55% of ICU patients are weaned&#xD;
        from MV prematurely, and that approximately 20% experience difficult and prolonged weaning.&#xD;
        In Argentina, our country, there are reports that this population amounts to 49.3%. One&#xD;
        common denominator in the literature, international and national, regarding this section, is&#xD;
        that such patients have more days of MV, ICU and hospital stay.&#xD;
  &#xD;
        During prolonged weaning, monitoring of muscular effort becomes essential: both excessive and&#xD;
        deficient efforts usually lead to diaphragmatic dysfunction. The former predisposes to&#xD;
        fatigue, while the latter to atrophy. In this context, it is vital to implement&#xD;
        &quot;diaphragmatic protection&quot; strategies, which consist of programming the level of assistance&#xD;
        with a focus on muscular effort or muscular pressure (PMUS) to keep it within a target range.&#xD;
  &#xD;
        The reference method for measuring inspiratory effort is the Pressure-Time Product of the&#xD;
        esophagus (PTPESO), which involves the magnitude of PMUS measured through the change in&#xD;
        esophageal pressure (PES) generated during inspiration, its duration, and respiratory rate&#xD;
        (RR). For patients on partial ventilatory support, a PTP of 50 to 150 cmH2O/sec/min is&#xD;
        recommended. Thus, PES becomes an everyday and reference tool for the management of patients&#xD;
        with prolonged weaning from MV.&#xD;
  &#xD;
        Recently, Bertoni et al. proposed measuring Occlusion Pressure (POCC) as a non-invasive&#xD;
        method, i.e., without the need to evaluate PES, to estimate the magnitude of PMUS and program&#xD;
        assistance in PSV. By means of a tele-expiratory occlusion maneuver of the airway, the&#xD;
        maximum negative deflection of the signal during the patient's inspiration is quantified.&#xD;
        This maneuver is called POCC. Then, through a simple multiplication by a constant, the value&#xD;
        of PMUS in one cycle is obtained. Given the ease of measurement and its non-invasive nature,&#xD;
        this technique has taken a leading role in the approach to patients during partial support at&#xD;
        present.&#xD;
  &#xD;
        Although the POCC is validated to quantify breathing effort, it has significant weaknesses.&#xD;
        Some of these are that it only values the maximum deflection in an average of efforts, does&#xD;
        not consider the time that the effort made by the patient lasts, nor the respiratory rate,&#xD;
        two fundamental variables in terms of tolerance to the load (duration of contraction and&#xD;
        frequency of repetition).&#xD;
  &#xD;
        In this context, having a method that can estimate PTPESO non-invasively would be extremely&#xD;
        useful to titrate the level of assistance in the framework of diaphragmatic protection&#xD;
        strategies in patients with difficulties in being weaned from MV.&#xD;
  &#xD;
        Therefore, the investigators propose the following study that will validate the measurement&#xD;
        of PTPESO based on POCC, but considering the inspiratory time and respiratory rate to obtain&#xD;
        PTP per breath and per minute. These variables will be called PTPPOCC-br and PTPPOCC-min,&#xD;
        respectively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Airway Occlusion Pressure</measure>
      <time_frame>At the end of the study, estimated in July 2024</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Esophageal Pressure Time product per breath (PTPESOF-br) and per minute (PTPESOF-min)</measure>
      <time_frame>At the end of the study, estimated in July 2024</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Weaning Failure</condition>
    <arm_group>
      <arm_group_label>Patients with prolonged weaning</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>End expiratory occlusion maneuver</intervention_name>
      <description>An end expiratory occlusion maneuver will be performed during pressure support ventilation in patients with prolonged weaning.</description>
      <arm_group_label>Patients with prolonged weaning</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients over 18 years of age with prolonged weaning from mechanical ventilation, who are&#xD;
          in the intensive care units of the following hospitals: Hospital Italiano, Hospital&#xD;
          Británico, Centro de Educación Médica e Investigaciones Clínicas 'Norberto Quirno' and&#xD;
          Sanatorio Anchorena de San Martín, will be included&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with mechanical ventilation, who failed 3 or more spontaneous breathing&#xD;
               trials&#xD;
  &#xD;
            -  Esophageal balloon placed&#xD;
  &#xD;
            -  Who can trigger the ventilator&#xD;
  &#xD;
            -  With hemodynamic stability&#xD;
  &#xD;
            -  with P/F ratio above 150&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  under 18 years old of age&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  do not resuscitate order or expected poor short term prognosis&#xD;
  &#xD;
            -  refuse to sign the informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emilio Steinberg, RT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Italiano</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emilio Steinberg, RT</last_name>
      <phone>+11 64977663</phone>
      <email>emilio.steinberg@hospitalitaliano.org.ar</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centro de Educación Médica e Investigaciones Clínicas &quot;Norberto Quirno&quot;</name>
        <address>
          <city>Buenos Aires</city>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Mariano Setten, RT</last_name>
        <phone>+ 54 11 5299-0100</phone>
        <email>marianosetten@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Británico</name>
        <address>
          <city>Buenos Aires</city>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Emiliano Gogniat, RT</last_name>
        <phone>+54 11 4309-6400</phone>
        <email>emilianogogniat@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Gustavo Plotnikow, RT</last_name>
        <phone>+54 11 4309-6400</phone>
        <email>gplotnikow@gmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Hospital Italiano de Buenos Aires</name>
        <address>
          <city>Buenos Aires</city>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Emilio Steinberg, RT</last_name>
        <phone>+54 11 4959-0200</phone>
        <email>emilio.steinberg@hospitalitaliano.org.ar</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sanatorio Anchorena San Martín</name>
        <address>
          <city>Buenos Aires</city>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Javier Dorado, RT</last_name>
        <phone>+54 0800-222-7276</phone>
        <email>javierhdorado@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Argentina</country>
    </location_countries>
    <reference>
      <citation>Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.</citation>
      <PMID>27626706</PMID>
    </reference>
    <reference>
      <citation>Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.</citation>
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    </reference>
    <reference>
      <citation>Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.</citation>
      <PMID>17470624</PMID>
    </reference>
    <reference>
      <citation>Brault C, Mancebo J, Suarez Montero JC, Bentall T, Burns KEA, Piraino T, Lellouche F, Bouchard PA, Charbonney E, Carteaux G, Maraffi T, Beduneau G, Mercat A, Skrobik Y, Zuo F, Lafreniere-Roula M, Thorpe K, Brochard L, Bosma KJ. The PROMIZING trial enrollment algorithm for early identification of patients ready for unassisted breathing. Crit Care. 2022 Jun 23;26(1):188. doi: 10.1186/s13054-022-04063-4.</citation>
      <PMID>35739553</PMID>
    </reference>
    <reference>
      <citation>Brochard L, Martin GS, Blanch L, Pelosi P, Belda FJ, Jubran A, Gattinoni L, Mancebo J, Ranieri VM, Richard JC, Gommers D, Vieillard-Baron A, Pesenti A, Jaber S, Stenqvist O, Vincent JL. Clinical review: Respiratory monitoring in the ICU - a consensus of 16. Crit Care. 2012 Dec 12;16(2):219. doi: 10.1186/cc11146.</citation>
      <PMID>22546221</PMID>
    </reference>
    <reference>
      <citation>Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.</citation>
      <PMID>3988680</PMID>
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    <reference>
      <citation>Combes A, Costa MA, Trouillet JL, Baudot J, Mokhtari M, Gibert C, Chastre J. Morbidity, mortality, and quality-of-life outcomes of patients requiring &gt;or=14 days of mechanical ventilation. Crit Care Med. 2003 May;31(5):1373-81. doi: 10.1097/01.CCM.0000065188.87029.C3.</citation>
      <PMID>12771605</PMID>
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      <citation>Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.</citation>
      <PMID>30113379</PMID>
    </reference>
    <reference>
      <citation>Dianti J, Fard S, Wong J, Chan TCY, Del Sorbo L, Fan E, Amato MBP, Granton J, Burry L, Reid WD, Zhang B, Ratano D, Keshavjee S, Slutsky AS, Brochard LJ, Ferguson ND, Goligher EC. Strategies for lung- and diaphragm-protective ventilation in acute hypoxemic respiratory failure: a physiological trial. Crit Care. 2022 Aug 29;26(1):259. doi: 10.1186/s13054-022-04123-9.</citation>
      <PMID>36038890</PMID>
    </reference>
    <reference>
      <citation>Dorado JH, Navarro E, Plotnikow GA, Gogniat E, Accoce M; EpVAr Study Group. Epidemiology of Weaning From Invasive Mechanical Ventilation in Subjects With COVID-19. Respir Care. 2023 Jan;68(1):101-109. doi: 10.4187/respcare.09925. Epub 2022 Nov 15.</citation>
      <PMID>36379638</PMID>
    </reference>
    <reference>
      <citation>Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.</citation>
      <PMID>23631814</PMID>
    </reference>
    <reference>
      <citation>Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.</citation>
      <PMID>32516052</PMID>
    </reference>
    <reference>
      <citation>Jonkman AH, Rauseo M, Carteaux G, Telias I, Sklar MC, Heunks L, Brochard LJ. Proportional modes of ventilation: technology to assist physiology. Intensive Care Med. 2020 Dec;46(12):2301-2313. doi: 10.1007/s00134-020-06206-z. Epub 2020 Aug 11.</citation>
      <PMID>32780167</PMID>
    </reference>
    <reference>
      <citation>Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.</citation>
      <PMID>10816184</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27334266</PMID>
    </reference>
    <reference>
      <citation>Penuelas O, Muriel A, Abraira V, Frutos-Vivar F, Mancebo J, Raymondos K, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Ferguson ND, Del Carmen Marin M, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Amin P, Cakar N, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Esteban A. Inter-country variability over time in the mortality of mechanically ventilated patients. Intensive Care Med. 2020 Mar;46(3):444-453. doi: 10.1007/s00134-019-05867-9. Epub 2020 Jan 7.</citation>
      <PMID>31912203</PMID>
    </reference>
    <reference>
      <citation>Su PL, Kao PS, Lin WC, Su PF, Chen CW. Limited predictability of maximal muscular pressure using the difference between peak airway pressure and positive end-expiratory pressure during proportional assist ventilation (PAV). Crit Care. 2016 Nov 27;20(1):382. doi: 10.1186/s13054-016-1554-4.</citation>
      <PMID>27888836</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Italiano de Buenos Aires</investigator_affiliation>
      <investigator_full_name>EMILIO MARTIN STEINBERG</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>mechanical ventilation</keyword>
    <keyword>weaning</keyword>
    <keyword>breathing effort</keyword>
    <keyword>occlusion pressure</keyword>
    <keyword>pressure time product</keyword>
    <keyword>pressure support ventilation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040138
  org study id: 6810
  nct id: NCT06040138
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Airway Occlusion Pressure
  time frame: At the end of the study, estimated in July 2024
  description: 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.
  measure: 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
  description: 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.
  arm group label: Patients with prolonged weaning
  description: 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.
  intervention type: Diagnostic Test
  intervention name: End expiratory occlusion maneuver
  description: An end expiratory occlusion maneuver will be performed during pressure support ventilation in patients with prolonged weaning.
  arm group label: Patients with prolonged weaning
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emilio Steinberg, RT
  role: Principal Investigator
  affiliation: Hospital Italiano
  last name: Emilio Steinberg, RT
  phone: +11 64977663
  email: emilio.steinberg@hospitalitaliano.org.ar
  facility: 
  contact: 
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  contact backup: 
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  country: Argentina
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  PMID: 27626706
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  responsible party type: Principal Investigator
  investigator affiliation: Hospital Italiano de Buenos Aires
  investigator full name: EMILIO MARTIN STEINBERG
  investigator title: Principal Investigator
  mesh term: Respiratory Insufficiency
  sharing ipd: No