An interventional study of Hyperinflation with mechanical ventilator and Manual hyperinflation in Sepsis, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Diagnostic
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Among 49 studies in Sepsis with a site in Brazil — 4 open to participants now, 6 under way, 1 of them phase 3. Sepsis · Brazil.
Among the 49 studies in Sepsis with a site in Brazil, this one is the 36th largest by planned enrollment of the 39 interventional ones that give a count, is one of 5 that started in 2018, is one of 12 with no phase, and was the 31st registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →4 of the 49 studies in Sepsis with a site in Brazil are open now. Recruiting first, the newest first:
Hospital Israelita Albert Einstein · Sites in Brazil
Ages 18+
University of Sao Paulo · Sites in Brazil
Ages 18+
Jerry Zimmerman · Sites in Brazil, United States, Canada and 7 more countries
Ages 1 mo–17 yrs
Federal University of São Paulo · Sites in Brazil
Ages 18+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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49 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 13 · Phase 4 6
First in 2002; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 152 across the 39 interventional studies, 160 across the 9 observational. Of the 35 that completed or were terminated, 4 (11%) have results posted.
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9 of 49 have an industry lead sponsor. The 10 most frequent:
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Hospital de Clinicas de Porto Alegre has 3 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
1 of the studies in Sepsis with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502794Hospital Israelita Albert EinsteinLong-term Assessment of Patients Treated in the ICU for Sepsis | 2027-06 |
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Among the 49 studies in Sepsis with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Due to the failure of the respiratory system, many patients admitted to the Intensive Care Units (ICUs) require the institution of invasive mechanical ventilation (MV), aiming at maintaining gas exchange, reversing respiratory muscle fatigue, among other benefits. However, an artificial airway installation may be harmful because of its deleterious capacity to the mucociliary clearance mechanism, predisposing to the accumulation of secretions and consequent respiratory infections. Physiotherapy in patients critical for the purpose of preventing and treating these respiratory complications. In this way, they are techniques that aim at a reexpansion and removal of airborne secretions. An application of manual hyperinflation with the Ambú (HM), applied through compression of the resuscitator (Ambu), an application of hypertension for the use of energy, pulmonary volume. Similar to the goal of manual hyperinflation, a hyperinflation maneuver without mechanical ventilator (HVM) is also widely used and has been shown to be effective. A maneuvering visa re-expansion of collapsed lung areas and increased peak expiratory flow, resulting in the mobilization of secretions. It is known that these techniques can cause deleterious effects to the lungs due to the high volumes administered and the variation in airway depression, predisposing to barotrauma and volutrauma, increasing the lung permeability and consequent pulmonary edema. There may also be a more subtle form of injury, such as a release of lung mediators, initiating a process of local inflammation. This biological response is called biotrauma, and if these mediators translocate into the systemic circulation, it can lead to dysfunction and death. The aim of the present study was to evaluate the biomarkers of pulmonary lesion in the hyperinflation maneuver with mechanical ventilator versus manual hyperinflation with environments in sudden patients under mechanical ventilation.
This study aims to evaluate the biomarkers of lung injury in the hyperinflation maneuver with mechanical ventilator versus manual hyperinflation with ambu in septic patients under mechanical ventilation through changes in the cellular levels of interleukin 8 (IL-8) and receptor for advanced glycation end products (RAGE). As specific objectives, compare the variables of ventilatory mechanics (dynamic compliance, static complacency, frequency airway resistance) and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate) before and after each maneuver and between groups. It is characterized as a randomized clinical trial. The binary randomization of the groups will be performed using the electronic application Bracket RTSM (version 2.0.0, Bracket Global), and will be performed by a blind researcher to the groups evaluated. After the eligibility criteria, the selected patients will be randomized and divided into two groups : Hyperinflation group with mechanical ventilator (HVM) and manual hyperinflation group (HM). Triage will be carried out daily in order to detect patients eligible to apply the study through communication with the local multiprofessional team. Once patients are eligible according to the inclusion and exclusion criteria, randomization will be performed to determine the techniques to be employed. Prior to the application of each technique, all patients will be placed in the dorsal decubitus (DD) with the head elevated at 30 degrees and will be aspirated by the nursing team once with probe number nº 14 and with a vacuum of -40cmH2O. Five minutes later, a 4.5 mL blood sample from the study participant for analysis of lung injury biomarkers (IL-8 and RAGE) will be collected in an EDTA tube. Blood samples will be sent to the Molecular and Protein Analysis Unit (UAMP) of the HCPA Experimental Research Center (CPE) in a box cooled by a blind collaborator who is not part of the study and will be stored at -80ºC. The biomarkers will be tested in duplicates through the plasma of the sample collected using the Luminex Human Magnetic Assay kit (R \& DSystems, Minneapolis, MN). The results will be transcribed to the datasheet. A period of five minutes will be waited for the start of the initial technique chosen by randomization. When drawn to the HVM group, there will be an increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O. During the application of this technique VC will increase significantly in most patients, which may cause and / or increase Auto-PEEP. In order to minimize and / or extinguish this adverse effect the RF should be reduced to allow exhalation. When drawn to the HM group, the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute. Data will be collected on ventilatory mechanics (dynamic compliance, expiratory tidal volume, respiratory rate, peak pressure, plateau pressure, airway resistance) from the ventilator used in the SERVO-s® institution and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate) in the hemodynamic monitoring device MP60® before and after the application of each technique, and the data will be recorded on an evaluation form. After each maneuver, a period of three hours will be waiting and then a blood sample will be collected again from the patient for the analysis of lung injury biomarkers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
When randomized to the Hyperinflation with mechanical ventilator (HVM) group, there will be an increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O
Device: Hyperinflation with mechanical ventilator
When randomized to the Manual hyperinflation (HM) group, the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute.
Device: Manual hyperinflation
increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O
the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute.
Interleukin 8 (IL-8)
A sample of 4.5 mL of blood from the study participant for analysis of lung injury biomarkers will be collected in an EDTA tube and then analyzed using the Luminex Human Magnetic Assay kit
Time frame: variation in 3 hours
Receptor for advanced glycation end products (RAGE)
A sample of 4.5 mL of blood from the study participant for analysis of lung injury biomarkers will be collected in an EDTA tube and then analyzed using the Luminex Human Magnetic Assay kit
Time frame: variation in 3 hours
Systolic blood pressure
will be verified through the Philips MP60® hemodynamic monitoring device
Time frame: variation in 3 hours
Diastolic blood pressure
will be verified through the Philips MP60® hemodynamic monitoring device
Time frame: variation in 3 hours
Heart rate
will be verified through the Philips MP60® hemodynamic monitoring device
Time frame: variation in 3 hours
Mean arterial pressure
will be verified through the Philips MP60® hemodynamic monitoring device
Time frame: variation in 3 hours
Respiratory rate
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Dynamic compliance (cdyn)
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Static compliance (cst)
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Peak inspiratory pressure (PIP)
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Plateau pressure (PP)
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Airway resistance (Raw)
value obtained from the ventilator used in the institution SERVO-s®
Time frame: variation in 3 hours
Started Mar 2018 (actual). Primary completion is estimated for Sep 2019, 17 months after the start.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 17 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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