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Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01992224
Enrollment
2
Registered
2013-11-25
Start date
2012-07-31
Completion date
2016-06-30
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Complication of Ventilation Therapy

Keywords

severe acute pancreatitis, mechanical ventilation

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.

Interventions

OTHERearly 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

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

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mechanical Ventilation Time28 days

Secondary

MeasureTime frame
the incidence of ventilation associated pneumonia28 days

Other

MeasureTime frameDescription
mortality60 days
the incidence other complications of mechanical ventilationparticipants will be followed for the duration of hospital stay, an expected average of 2 monthspatient-mechanic desynchronization, pneumothorax, atelectasis
hospital staythe participants will be followed till the discharge, an expected average of 2 months

Countries

China

Contacts

Primary ContactErzhen CHEN, MD
chenerzhen@hotmail.com86-13901753478
Backup ContactEnqiang MAO, MD
86-13501747906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026