Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Not Applicable

• Conditions: Acute Pancreatitis; Complication of Ventilation Therapy
• Interventions: Other: early mechanical Ventilation; Other: Conventional Mechanical Ventilation

• Registration Number: NCT01992224
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25
• Primary Completion: 2015-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early mechanical ventilation	early mechanical Ventilation	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
conventional mechanical ventilation	Conventional Mechanical Ventilation	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

Primary Outcome Measures

Name	Time	Method
Mechanical Ventilation Time	28 days

Secondary Outcome Measures

Name	Time	Method
the incidence of ventilation associated pneumonia	28 days

Trial Locations

Locations (1)

Department of EICU, Ruijin Hospital; 🇨🇳 Shanghai, China