Development of Pulmonary Dysfunction Following Open Abdominal Surgery
Conditions
Keywords
mechanical ventilation, lung function, abdominal surgery, open, systemic inflammation
Brief summary
Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.
Interventions
OTHERVariable Ventilation
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* elective open abdominal surgery * ASA classification 2-3 * age between 18 und 85 yrs * expected duration of surgery \> 3 h * expected extubation in the operation room * written informed consent
Exclusion criteria
* chronic lung disease (except to COPD stadium I and II, and asthma) * Body Mass Index (BMI) \> 40 * allergy to one of the drugs to be used for general anesthesia * participation in another interventional trial within 4 weeks before enrollment * addiction or any other disease that may interfere with the capacity of giving informed consent * pregnant or breastfeeding women * women in reproductive age, except to those who fulfill one of the following: * post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH \> 40 mlU/ml * post-operative (6 weeks after two-sided ovariectomy) * routine and correct use of anticonceptional methods with failure rate \< 1 % per year * sexually not active * vasectomy of the partner * indication of low compliance with the protocol * contraindication for MRI examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced vital capacity | Preoperative until 5th postoperative day | Forced vital capacity is assessed on the first postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak expiratory flow | Preoperative until 5th postoperative day | — |
| Forced expiratory volume after 1 sec | Preoperative until 5th postoperative day | Forced expiratory volume after 1 sec (FEV1) on first postoperative day |
| PaO2/FIO2 | Preoperative until 5th postoperative day | PaO2/FIO2 during the intraoperative period |
| Arterial partial CO2 pressure | Preoperative until 5th postoperative day | PacO2 on the first postoperative day |
| Atelectasis | Preoperative until 5th postoperative day | Amount of lung atelectasis on the first postoperative day |
| Postoperative pulmonary complications | Preoperative until discharge from hospital | Development of postoperative pulmonary complications |
| Inflammation markers | Preoperative until 5th postoperative day | Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma |
| Distribution of ventilation | Preoperative until 5th postoperative day | Distribution of ventilation in lungs |
Countries
Germany
Outcome results
None listed