Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; ARDS
• Intervention / Treatment: Drug: Meropenem; Device: ventilator; Procedure: bronchoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ta'if, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with age group between 18-65 years,patients Respiratory failure, patients with pneumonia

Exclusion Criteria:

• pediatric patients, patients with anoxic brain insult

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; patients of group A Continue on the conventional way of ventilation and . Microbiological results collected from patients of group A through qualitative sputum.	Drug: Meropenem; all patients in both groups receive meropenam and put on the ventilators for 2 weeks; Device: ventilator; ventilator
Active Comparator: Group B; had three times bronchoscopy 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, 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	Drug: Meropenem; all patients in both groups receive meropenam and put on the ventilators for 2 weeks; Device: ventilator; ventilator; Procedure: bronchoscopy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients weaned from the ventilator	those who had improvement in all parameters of sepsis (SOFA score) and improvement in (CPIS) score	2 weeks
number of patients disharged from ICU	Those who weaned from the ventilator and recoverd from sepsis	2 weeks

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: ICU-40-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes