Research VT of 6-8ml/kg of ideal body

Research
Project Proposal

Title:

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The Association between the Initial
PEEP Setting and the Development of Pulmonary Complications in Adult Patients Without
Lung Injury: a randomized controlled trial

1.    
Abstract:

Background: Over the last few decades, the lung
protective strategy has become stander of care for ARDS patients and proved to
be a strategy to prevent Acute-lung injury (ALI) for patients with no previous
lung injury. The current data regarding the
initial PEEP setting with lung protective ventilation for adult patient without
ARDS are conflicting.  Objective: The main aim of this study is to investigate the association
between the initial PEEP setting (8cm H2O vs. 5cm H2O) and
the development of pulmonary complications in adult patients without lung injury.

Methods: This is a randomized controlled research design. All adult patients at age of ?18
years old and required mechanical ventilation for more than 48 h will be
eligible to participate in this study. Subjects will be randomly allocated to receive
initial PEEP of 8 cm H2O or PEEP of 5 cm H2O. The primary
outcome will be pulmonary complications and duration of mechanical ventilation.

2.    
Context:

 

Over last few decade lung protective
strategy has become stander of care for ARDS patients and proved to be the best
strategy to prevent ALI for patients with no previous lung injury. (Acute
Respiratory Distress Syndrome Network et al., 2000) (Serpa Neto et al., 2012)
Several studies showed that the use of low tidal volume for adult mechanically
ventilated patient without ARDS improved the clinical outcomes and decrease the
risk of pulmonary complication. (Fuller, Mohr, Drewry, & Carpenter, 2013) (Gu,
Wang, & Liu, 2015) (Yang, Grant, Stone, Wu, & Wick, 2016) (Choi et al.,
2006) They concluded that VT of 6-8ml/kg of ideal body weight (IBW) prevented
potential pulmonary complications and reduce the duration of mechanical
ventilation. Most of those studies used to set PEEP at > 5 cmH2O, and some studies did not report the
initial PEEP. (Fuller et al., 2013) (Gu et al., 2015) (Yang et al.,
2016) (Choi et al., 2006)

 

When low tidal volume of 6ml/kg used;
adequate PEEP level will be needed to prevent atelectrauma and improves gas
exchanges. Lung injury may occur because of an inappropriate PEEP setting as a
result of either overdistention of the lung or from repeated opening and
closing of alveoli throughout the respiratory cycle. (Cressoni, Chiurazzi,
Chiumello, & Gattinoni, 2017) Moreover, the effect of PEEP level in
pulmonary parenchyma was most frequently studied in ARDS and ALI patients. (Briel
et al., 2010) (Brower et al., 2004). Those studies showed insight into the
different PEEP level on lung tissue. Most of the trials which investigate the
benefits of protective strategy for patients with ARDS recommended the use of
high PEEP. Meta-analysis studies by Briel et al and Phoenix et al demonstrated
that as a part of lung-protective ventilation higher level of PEEP was associated
with an increase survival rate of patient with ARDS. (Phoenix, Paravastu,
Columb, Vincent, & Nirmalan, 2009) (Briel et al., 2010) However, multiple
randomized control trials showed that there were no
significant differences in the clinical outcome
when high PEEP compared to low PEEP in ARDS patient. (Brower
et al., 2004) (Meade et al., 2008) (Mercat et al., 2008) (Villar, Kacmarek,
Perez-Mendez, & Aguirre-Jaime, 2006)

Additionally,
Hansen et al compared initial PEEP of 5cm H2O and PEEP of 8cm H2O
in postoperative patients with coronary artery bypass grafting (CAPG). All
patients were without preexisted lung injury and both groups were placed in the
low tidal setting. They found that the group with PEEP of 8cm H2O
had longer hospitalization time. However, there were no significant differences
between both groups in hospital death and aspiration pneumonia (Hansen et al.,
2015). Hong and colleagues published a study examining different level of PEEP with
low tidal volume. They found low tidal volume with PEEP of 10 cm H2O
was associated to increase pulmonary infection and lung injury. (Hong et al.,
2010) Furthermore, there were clinical trials that showed the benefit of low
tidal volume and high PEEP in patient without lung injury when it was compared
to high tidal volume without PEEP. (Wolthuis et al., 2008) (Choi et al., 2006)Wolthuis
et al used tidal volume 6ml/kg of IBW and 10 cmH2O PEEP that showed reduction
in pulmonary inflammation. (Wolthuis et al., 2008) Most clinicians selected
initial PEEP of 5 or 8 cm H2O (Hansen et al., 2015). Manzano et al
studied the used of PEEP from 5-8cm H2O with non-injured lungs. They
conclude PEEP between 5 to 8 cm H2O reduce ventilator associated
pneumonia significantly when compared to PEEP of 0 cmH2O. (Manzano
et al., 2008)

Several articles have described
different ways of determining when the goals of PEEP have been achieved for adult
mechanical ventilated patients. The consensus of these different approaches is
reviewed. (Cressoni et al., 2017) Some clinicians follow a specific step
increase in FiO2 and PEEP according to the procedure outlined in the
ARDSnet study. Others followed a more rapidly increasing PEEP to FiO2
table from a follow-up study. Both the low and high PEEP titration techniques
for establishing the appropriate PEEP level appear to have similar morbidity
and survival rates.

PEEP setting may lead to ventilation
associated events. It is clear if PEEP progressively increases, it will result
in stressing lung tissue leading to pulmonary completions. The studies have
been shown that the PEEP had no significant effects on lung until 15cm H2O
was used. (Meade et al., 2008) However, according to the Centers for Disease
Control and Prevention, Ventilators Associated Evens (VAEs) may occur with an increase of PEEP
of ? 3cm H2O over the daily minimum PEEP in the baseline period, for
? 2 days. (Magill et al., 2013) It also has to be maintained for at least 1
hour. There
are limited researches examining the appropriateness and impact of initial PEEP setting in non-injury lung when the lung protective
strategy is in used. We hypothesized that PEEP of 8cm H2O will be
associated with a decrease in VAEs and pulmonary complications. Existing
studies lack to provide definitive recommendation for the best initial PEEP
when low tidal volume applied for patient without ARDS.

3.    
Research
question:

 

Dose PEEP of 8cm H2O associated
with a reduction in pulmonary complications when compared with initial PEEP of
5cm H2O in adult mechanical ventilated patient
without lung injury?

 

4.    
Research
methods:

This is a randomized controlled research design. After research approval, inform consent will be
obtained from all subjects. All adult patients at age of ?18 years old and required mechanical ventilation for more than 48 h
will be eligible to participate in this study. Patients will be excluded if
they are dying or extubated
within 48 hours, chronic mechanical ventilation, tracheostomized, history
of any pulmonary diseases, use of immunosppressive medication, recent
infection, brain death and ARDS.

To
obtain a sample that represented the target population, participants will be
randomly and voluntary self-selected. The sample size will be approximately two
hundred.

The ventilation protocol will
consider Pressure-Regulated Volume Control (PRVC) mode or similar mode of
mechanical ventilation with initial setting of 6ml/kg tidal volume (VT)
of IBW, respiratory rate (RR) to get minute ventilation of 100ml/kg, inspiratory
to expiratory ratio (I:E) to be set not more than 1:1, an inspiratory oxygen
fraction of .50 and pressure limits at 30 cmH2O. Subjects will be randomly
allocated to receive initial PEEP of 8cm H2O or PEEP of 5cm H2O.

After initial adjustment, the clinicians will be allowed to increase tidal
volume up to 8 ml/kg and respiratory rate up to 35 breaths per minute to manage
PaCO2.  Additionally, they are
allowed to adjust FiO2 and PEEP according to the procedure outlined
in the ARDSnet study.

Baseline clinical history and
demographic information will be obtained from the patient’s medical record. Following the initiation
of mechanical ventilation, all ventilator settings and
available hemodynamic parameters will be measured and recorded daily. Also,
arterial blood gas, bronchoalveolar lavage and chest radiographic data will be
performed daily. There are eight variables will be measured within our research; three
dependent variables and five independent variables. The dependent variables are
VAEs incidence, ARDS incidence and duration of
mechanical ventilation. While, the independent variables are age, gender, diagnosis, BMI and smoking history.

The primary
outcome will be pulmonary complications and duration of mechanical ventilation.

Pulmonary complications will include ARDS and VAE. All personal
information will be kept completely confidential. The records will not have any
identifying information on them. All data accessible only to the investigators.

The outcome
data will be collected and compared with the baseline
characteristics of experimental and control groups to measure the association between the initial PEEP setting and the development of pulmonary
complications. The mean and median information will be calculated, stander
division and t-test analysis comparing the baseline result will be done to
determine the significance (P<.05 for categorical data the chi-square test will be used. differences within both groups analyzed with a wilcoxon signed-rank paired sample and mann-whitney u test. all statistical analyses performed spss>

 

5.    
Research
significance:

 

The finding of this study will present an
evidence about the association between the initial
PEEP setting and the development of pulmonary complications in adult patient
without lung injury. Currently, there are limited researches
examining the appropriateness and impact of initial
PEEP setting in healthy lung when the lung protective strategy is in used
(6ml/kg of IBW). Existing studies lack to provide definitive recommendation for
the best initial PEEP when low tidal volume applied for patient without ARDS.

We hypothesized that PEEP of 8cm H2O will be associated with a
decrease in pulmonary complications.