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Comparative study of using a Protocol for monitoring Endotracheal tube cuff pressure versus unmonitored endotracheal tube cuff pressure in mechanically ventilated children.

RESEARCHER: DR YESHWANTH GUIDE: DR FARHAN SHAIKH

INTRODUCTION The use of endotracheal tubes (ETTs) for the provision of mechanical ventilation occurs in approximately one third of paediatric intensive care unit (PICU) patients. (1) Common teaching in the past opposed the use of cuffed ETTs in children younger than 8 years because of the risk of injuring the submucosa at the level

of the cricoid ring, leading to subglottic airway oedema and airway compromise at the time of extubation(2,3,4) Prior to 2005 editions, PALS too recommended uncuffed ETT in young children.

• However, studies conducted in the past 2 decades have concluded there were no differences in post-extubation subglottic oedema, the rate of successful extubation or the need for tracheotomy between those with cuffed and uncuffed ETT in any age group. (5,6)

• There are inherent risks with the use of ETT (cuffed and uncuffed). The development of post extubation stridor (PES) is a particularly important risk. It is a sign of post-extubation airway oedema, which results in short-term morbidity with increased length of mechanical ventilation and intensive care unit length of stay. (5) • Post extubation stridor occurs in 6% to 30% of extubation in PICUs, resulting in reintubation 2% to 6% of the time.(8,9,11) This is of particular interest because of the 5-fold increased risk of mortality in children who require reintubation.(5,10)

• Although above studies supported the equal safety of using cuffed ETTs compared with uncuffed tubes in children, there are few studies in literature described if monitoring and limiting cuff pressures as an intervention will decrease the rate of PES in a critical care unit that previously had no standardized practice in using cuffed tubes. • In 2016, a study was published in Journal of Critical Care

“Impact of monitoring endotracheal tube cuff leak pressure on post-extubation stridor in children“- However this was retrospective study (12) • We sought to determine if instituting, as a quality improvement intervention, the practice of measuring and maintaining cuff leak pressures according to protocol would decrease the rate of PES in the PICU. This is Prospective study

AIM

To study whether a protocol of monitoring Endotracheal tube cuff pressure every 6 hourly is a better approach than adjusting the endotracheal tube pressures by monitoring the leak displayed on ventilator without actually monitoring the endotracheal tube cuff pressure.

OBJECTIVES • Primary objective:

• To find out whether scheduled Endotracheal tube cuff pressure monitoring decreases post extubation stridor. • Secondary objective: • To study whether scheduled monitoring of ET cuff pressure versus standard care has any effect on1.

Duration of mechanical ventilation (days)

2.

VAP (rate of VENTIALTOR ASSOCIATED PNEUMONIA)

3.

Rate of Re-intubation

4.

Total duration of PICU stay (days)

METHODOLOGY This is a prospective interventional study done at level-3 PICU (Rainbow children's hospital, Hyderabad) for study period of 1 year (1st JUNE 2017 to 31st May 2018)

• Patients will be included as per inclusion criteria. • Decision regarding the size of the cuffed ETT is decided by following

the modified Cole formula [ETT inner diameter = (Age in years/4) + 3.5] & the treating physician.

INCLUSION CRITERIA • All children between age group 1 month to 18 year intubated with cuffed Endotracheal tube and mechanically ventilated.

Exclusion criteria: • age group <1 month and >18 year • patients who were ventilated for upper airway obstruction / Upper air way anomalies. • intubated with uncuffed endotracheal tube • patients who expired during mechanical ventilation • Patients who were intubated at referral hospital

• Sample size 80 patients in each group • power 85% and • significance level 0.05 • Sample size 800 in each group • For pilot study – 10% is taken – 80 patients in each group

• After obtaining Written informed consent, all patients will be randomized

into two groups based on computer generated randomization-

• In group-A, after intubation, cuff will be inflated with volume of air mentioned on cuff by manufacturer. The cuff pressure as such will not be

monitored, however volume of air in the cuff shall be adjusted by looking at the leak displayed on the ventilator (Up to 20% leak is permissible) and /

or presence of leak at Peak Inspiratory Pressure (minimal leak technique)

• In group-B after intubation cuff will be inflated with cufflator and pressure will be kept between 20-30 cm of water. • Every 6th hourly cuff pressure will be monitored • Cuff pressure will be maintained between 20-30 cm of water.

• Manometer used to measure & adjust cuff pressure – Portex

• Amount of leak will be monitored from the display of the ventilator in both groups.

After extubation – • Incidence of Post Extubation Stridor (PES) shall be monitored. Patients were considered to have

PES if they received a dose of nebulized racemic epinephrine within 24 hours of the time of extubation. The need for racemic epinephrine was determined by the caring physician in the intensive care unit based on the clinical judgment of the presence of upper airway obstruction

features. • rate of VAP,

• total duration of ventilator support (days) and duration of PICU stay (days) will be noted in both groups.

• PROFORMA

• NAME

UHID NO:

• AGE:

SEX:

• DIAGNOSIS: • 1.Reason for intubation: Respiratory failure/Hemodynamic instability/Encephalopathy/Cardiac Failure/Others

• 2.Airway: •

Size & company of ET tube:



Intubating person: PG resident/1st yr Fellow/2nd yr Fellow/Anesthetist/Intensivist



RSI Used



Place of Intubation: PICU/ER/OT/Wards/Outside Hospital



Amount of air instilled in the Cuff.

No of attempts for intubation

• 3.Post extubation • Stridor (within 48 hrs.) : Y/N

Duration of Stridor(hrs.):

• Adrenaline nebulization: Y/N

No of Doses :

• Inj. dexamethasone (prior to extubation) : Y/N post Extubation : Y/N • Reintubation: Y/N

• Need of Non invasive ventilation: Y/N • 4.Secondary Outcomes:

• VAP: Y/N • Total duration of ventilator support: • Total duration of PICU stay: • Outcome: Discharge/Death/LAMA

HHFNC: Y/N

5.CUFF PRESSURE MONITORING Day 1/sign sign0 hrs-CP 0hrs-Leak 6hrs-CP 6hrs-Leak 12hrs-CP 12hrs-Leak 18hrs-CP 18hrs-leak

Day2/sign Day3 /sign

Day4/sign Day5

INFORMED CONSENT

references [1] Newth CJL, Venkataraman S, Willson DF, Meert KL, Harrison R, Dean JM, et al. Weaning and extubation readiness in pediatric patients. Pediatr Crit Care Med 2009;10:1–11. [2] Zuckerburg AL ND: Airway management in pediatric critical care. Rogers MC, Nichols DG, editors. Textbook of Pediatric Intensive Care. 3rd Edition: 63, 1996 [3] Zucker HA: The airway and mechanical ventilation. Chang AC, Hanley FL, Wernovsky G, Wessel, DL, editors. Pediatric Cardiac Intensive Care. : 95, 1998

[4] Thompson A: Pediatric Airway Management. Fuhrman, B, Zimmerman, J, editors. Pediatric Critical Care. 3rs edition: 492, 2006 [5] Kurachek SC, Newth CJ, Quasney MW, Rice T, Sachdeva RC, Patel NR, et al. Extubation failure in pediatric intensive care: a multiple-center study of risk factors and outcomes. Crit Care Med 2003;31:2657–64. [6] Weiss M, Dullenkopf A, Fischer J, et al: Prospective randomized controlled multicentre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. , 2009

[7] Fenmei Shi, Ying Xiao, Wei Xiong, Qin Zhou, Xiongqing Huang Cuffed versus uncuffed endotracheal tubes in children: a meta-analysis. J Anesth 2015 s00540-015-2062-4 [8] Deakers TW, Reynolds G, Stretton M, Newth CJL. Cuffed endotracheal tubes in pediatric intensive care. J Pediatr 1994;125:57–62. [9] Newth CJL, Rachman B, Patel N, Hammer J. The use of cuffed versus uncuffed endotracheal tubes in pediatric intensive care. J Pediatr 2004;144:333–7. [10] Edmunds S, Weiss I, Harrison R. Extubation Failure in a Large Pediatric ICU Population*.Chest 2001;119:897–900 [11] Tellez DW, Galvis AG, Storgion SA, Amer HN, Hoyseyni M. Dexamethasone in the prevention of postextubation stridor in children*. J Pediatr 1991;118:289–94. [12] Schneider James, Mulale Unami, Yamout Stephanie, Pollard Sharon, Silver Peter, Impact of Monitoring Endotracheal Tube Cuff Leak Pressure on Post Extubation Stridor in Children, Journal of Critical Care (2016) Khine HH, Corddry DH, Kettrick RG,Martin TM, McCloskey JJ, Rose JB. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia.Anesthesiology 1997;86:627–31

Till now • Group A - 73 CHILDREN (11 had PES, 4 -VAP) • GROUP B - 68 CHILDREN (8 had PES, 2 - VAP)

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