Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Study Overview
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Brief Summary
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Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.

Official Title
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Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Conditions
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Acute Pancreatitis, Complication of Ventilation Therapy

Intervention / Treatment
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* Other: early mechanical Ventilation
* Other: Conventional Mechanical Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012 the diagnosis of ARDS meets the criteria of Berlin definition Exclusion Criteria: chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma organic cardiopathy pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early mechanical ventilation<br>Fulfillment of three or more criteria below: respiratory rate > 28 per minute serum lactate > 3 mmol/L PaO2/FiO2 Index <300 mmHg SvO2 < 65% lung infiltration or atelectasis, pleural exudation Abbreivation: PaO2, arterial partial pressure of oxygen; FiO2, fraction of inspired oxygen; SvO2, venous oxygen saturation | Other: early mechanical Ventilation<br>* Fulfillment of three or more criteria below: respiratory rate > 28 per minute serum lactate > 3 mmol/L PaO2/FiO2 Index <300 mmHg SvO2 < 65% lung infiltration or atelectasis, pleural exudation<br>|
| Experimental: conventional mechanical ventilation<br>other group who don't start early mechanical ventilation and fulfillment four criteria below: respiratory rate > 28 bpm dyspnea PaO2/FiO2 Index <200 mmHg Chest X-ray: lung infiltration exclude chronic heart failure and pulmonary disease | Other: Conventional Mechanical Ventilation<br>* other group who don't start early mechanical ventilation and fulfillment four criteria below: respiratory rate > 28 bpm dyspnea PaO2/FiO2 Index <200 mmHg Chest X-ray: lung infiltration exclude chronic heart failure and pulmonary disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Ventilation Time |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of ventilation associated pneumonia |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, severe acute pancreatitis