Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Shanghai Jiao Tong University

Status: Unknown

Conditions: Acute Pancreatitis; Complication of Ventilation Therapy

Treatments: Other: early mechanical Ventilation; Other: Conventional Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01992224

12411950500 (Other Grant/Funding Number)

SAP bundle -- MV

Details and patient eligibility

About

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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

early mechanical ventilation

Experimental group

Description:

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

Treatment:

Other: early mechanical Ventilation

conventional mechanical ventilation

Experimental group

Description:

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

Treatment:

Other: Conventional Mechanical Ventilation