As an important life sustaining support , mechanical ventilation has greatly promoted the development of modern intensive care units. However, mechanical ventilation can lead to ventilator-induced lung injury, including barotrauma, volutrauma, atelectrauma and biotrauma. All patients undergoing mechanical ventilation are at risk of barotrauma. A multicenter prospective cohort study of 5183 patients with mechanical ventilation showed that the incidence of pulmonary barotrauma was 3%. The incidence of pulmonary barotrauma varied according to the causes of mechanical ventilation: chronic obstructive pulmonary disease (3%), asthma (6%), chronic interstitial lung disease (10%), acute respiratory distress syndrome (7%) and pneumonia (4%).
At present, it is considered that one of the main causes of barotrauma is the increasing of transpulmonary pressure. Transpulmonary pressure is the difference between alveolar pressure and intrapleural pressure. The commonly adopted lung protective ventilation methods include: limiting plateau pressure less than or equal to 30 cmH2O, using small tidal volume ventilation (6-8 mL/kg ideal body weight) . All the above methods are to reduce trans-pulmonary pressure by reducing alveolar pressure. In addition to reducing alveolar pressure, increasing pleural pressure is another important way to reduce transpulmonary pressure and the incidence of barotrauma. At present, the main method is the use of neuromuscular blockade. However, there are many shortcomings in of neuromuscular blockade: 1. Time limit, generally not more than 48 hours; 2. Long-term use of neuromuscular blockade causes adverse reactions such as myopathy; 3. Neuromuscular blockade are only suitable for invasive mechanical ventilation patients, but not for non-invasive mechanical ventilation or high flow oxygen inhalation patients. Therefore, it is urgent to find other methods to reduce trans-pulmonary pressure and lung injury.
The investigators drew inspiration from the early mechanism of "iron lung" ventilator and the clinical practice of reducing trans-pulmonary pressure and lung injury in obese patients. In the early stage, the investigators carried out the clinical practice of extrapulmonary lung protection strategy, that is, to give thoracic band restraint to patients undergoing non-invasive mechanical ventilation so as to reduce chest wall compliance, which can be significantly reduced under the same inspiratory pressure and occurrence of barotrauma. However, the respiratory mechanics mechanism of this method still needs to be further studied to determine whether it can reduce the incidence of barotrauma by reducing transpulmonary pressure. It is accessible and inexpensive. The aim of this study was to determine the changes of transpulmonary pressure in patients with invasive mechanical ventilation before and after thoracic band fixation by esophageal manometry without spontaneous breathing.
| Condition or disease | Intervention/treatment |
|---|---|
| Mechanical Ventilation Ventilator-induced Lung Injury Transpulmonary Pressure | Device: thoracic band |
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Extrapulmonary Lung Protection Strategy for Patients With Mechanical Ventilation |
| Actual Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | August 1, 2021 |
| Estimated Study Completion Date : | August 1, 2021 |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||
| First Posted Date | May 13, 2019 | ||||
| Last Update Posted Date | August 5, 2019 | ||||
| Actual Study Start Date | August 1, 2019 | ||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Extrapulmonary Lung Protection Strategy for Patients With Mechanical Ventilation | ||||
| Official Title | Extrapulmonary Lung Protection Strategy for Patients With Mechanical Ventilation | ||||
| Brief Summary |
As an important life sustaining support , mechanical ventilation has greatly promoted the development of modern intensive care units. However, mechanical ventilation can lead to ventilator-induced lung injury, including barotrauma, volutrauma, atelectrauma and biotrauma. All patients undergoing mechanical ventilation are at risk of barotrauma. A multicenter prospective cohort study of 5183 patients with mechanical ventilation showed that the incidence of pulmonary barotrauma was 3%. The incidence of pulmonary barotrauma varied according to the causes of mechanical ventilation: chronic obstructive pulmonary disease (3%), asthma (6%), chronic interstitial lung disease (10%), acute respiratory distress syndrome (7%) and pneumonia (4%). At present, it is considered that one of the main causes of barotrauma is the increasing of transpulmonary pressure. Transpulmonary pressure is the difference between alveolar pressure and intrapleural pressure. The commonly adopted lung protective ventilation methods include: limiting plateau pressure less than or equal to 30 cmH2O, using small tidal volume ventilation (6-8 mL/kg ideal body weight) . All the above methods are to reduce trans-pulmonary pressure by reducing alveolar pressure. In addition to reducing alveolar pressure, increasing pleural pressure is another important way to reduce transpulmonary pressure and the incidence of barotrauma. At present, the main method is the use of neuromuscular blockade. However, there are many shortcomings in of neuromuscular blockade: 1. Time limit, generally not more than 48 hours; 2. Long-term use of neuromuscular blockade causes adverse reactions such as myopathy; 3. Neuromuscular blockade are only suitable for invasive mechanical ventilation patients, but not for non-invasive mechanical ventilation or high flow oxygen inhalation patients. Therefore, it is urgent to find other methods to reduce trans-pulmonary pressure and lung injury. The investigators drew inspiration from the early mechanism of "iron lung" ventilator and the clinical practice of reducing trans-pulmonary pressure and lung injury in obese patients. In the early stage, the investigators carried out the clinical practice of extrapulmonary lung protection strategy, that is, to give thoracic band restraint to patients undergoing non-invasive mechanical ventilation so as to reduce chest wall compliance, which can be significantly reduced under the same inspiratory pressure and occurrence of barotrauma. However, the respiratory mechanics mechanism of this method still needs to be further studied to determine whether it can reduce the incidence of barotrauma by reducing transpulmonary pressure. It is accessible and inexpensive. The aim of this study was to determine the changes of transpulmonary pressure in patients with invasive mechanical ventilation before and after thoracic band fixation by esophageal manometry without spontaneous breathing. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients admitted to the intensive care unit who need invasive mechanical ventilation at least 12 hours | ||||
| Condition |
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| Intervention | Device: thoracic band
Thoracic band fixation
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | August 1, 2021 | ||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03947476 | ||||
| Other Study ID Numbers | EXPECT | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Shanghai Zhongshan Hospital | ||||
| Study Sponsor | Shanghai Zhongshan Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Shanghai Zhongshan Hospital | ||||
| Verification Date | May 2019 | ||||