Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
Condition: ARDS; Septic Shock
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the
      ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.
    

Detailed description: 
      age group between 18-65 years, intubated and ventilated patients due to respiratory failure
      from severe lung infection and/or traumatic lung contusion [respiratory failure was diagnosed
      by arterial blood gases (ABG) with partial pressure of oxygen (PaO2) ≤60 mmHg, partial
      pressure of carbon dioxide (PaCO2)≥60 mmHg, PH > 7.30, respiratory rate >25 min]. All
      patients ventilated for 4 days with CMV with respiratory rate 12/min, PEEP 5 cm/H2O, FIO2
      adjusted to maintain arterial oxygen saturation above 90%. And sedated with both fentanyl and
      midazolam intravenous infusion to adjust sedation level to achieve Richmond
      Agitation-Sedation Scale (RASS) -2 to -3 as illustrated in table. All patients received broad
      spectrum antibiotics in form of meropenem 1 gm slowly intravenous every 8 hours in this
      period (four days) and a qualitative sputum culture collected from all patients after 3 days
      from ventilation. Feeding started on the second day of ventilation to all patients through
      feeding pump at rate of 70 ml insure plus (Abbot company) with 1.47 kilo-calorie/ml to supply
      patients with approximately 2500 kilo-calorie in 24 hours calculated by approximately 35
      kilo-calorie/kg. The 5 points of bundle for pneumonia prevention were strictly applied to all
      patients: Elevation of the head of the bed 30º to 45º, Daily evaluation for possible
      ex-tubation, The use of endotracheal tube with subglottic secretion drainage, oral care with
      oral antiseptics, initiation of safe enteral nutrition, within 24-48 hours from ICU admission
      and ventilation.

      200 patients included in our study from those who showed no improvement and still had
      respiratory failure and completed ventilation for 4 days and fulfilled > 2 parameters on SOFA
      score and > 6 on pneumonia score and randomly allocated in two groups 100 patients in each.
      Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1
      allocation using random block sizes of 2 and 4 by an independent doctor. In this way,
      sequence generation and type of randomization can be expressed at the same time.

      All patients selected underwent a percutaneous tracheostomy on the same day. Sepsis
      documented in our study by > 2 on Sequential Organ Failure Assessment (SOFA) score. While VAP
      documented in our study by >6 on CPIS score. Only patients of group B had three times
      bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at
      the end of the second 5 days and last one at the end of the studied period to confirm both
      clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used
      flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam
      and fentanyl infusion to get same sedation score mentioned before (RASS-2/-3), increase FIO2
      to 100% during the procedure, use xylocaine spray 10% by Astra Zeneca company 2 puffs in each
      nostril before application of the rubber tube of the bronchoscope, keep patient's head
      elevated 20 degree during procedure, use CMV mode with previous mentioned parameters with
      100% FIO2 during the procedure, 4 syringe of normal isotonic saline used for wash every one
      10 ml and suction done immediately after injection, suction of the fluid and small airway
      secretion after only the first injection of isotonic saline syringe used for BAL and sent for
      qualitative culture and the other isotonic saline injected in the remaining three syringe
      used only for wash the small airways and not for bacteriological sampling, monitoring of
      patients during the procedure done by SPO2, non-invasive blood pressure measurement every 5
      minutes, electro cardiac gram for heart rate, clinical assessment of depth of sedation every
      5 minutes.

      Duration of the study selected to be 2 weeks and evaluation of all patients in both groups
      done on three periods, at the end of the first 5 days, at the end of the second 5 days and at
      the end of last 4 days.
    

Intervention name(s): Meropenem; bronchoscopy; ventilator
Intervention type(s): Drug; Procedure; Device
Intervention description(s): all patients in both groups receive meropenam and put on the ventilators for 2 weeks; Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period; ventilator
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled > 2 parameters on SOFA score [9-10] and > 6 on CPIS score and randomly allocated in two groups 100 patients in each.
Masking: Single (Investigator)
Primary purpose: Treatment