Clinical trial NCT04014439: Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness
Official title: Relationship Between Neutrophil to Lymphocyte Ratio and Prealbumin Serum Levels With Diaphragm Thickness in Critical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Response
Keywords: diaphragm thickness
neutrophil to lymphocyte ratio
mechanical ventilation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are treated in intensive care unit and using mechanical ventilation from Day 0 till Day 5. These patients will be checked for their diaphragm thickness, level of prealbumin serums, and ratio of neutrophil to lymphocyte.

Brief summary: A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.

Detailed description: Weaning from ventilator sometimes can be failed and it happened due to several factors. One of the causes was Ventilator Induced Diaphragm Dysfunction (VIDD). This VIDD process occurred due to thinning process of the diaphragm thickness or decreased diaphragm muscle mass. The whole process happened due to inflammatory reaction that usually appeared on patients in Intensive Care Unit (ICU). Thus, this study was aimed to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.

Eligibility criteria: Inclusion Criteria:

* Critical patients treated in intensive care unit using mechanical ventilation from day 0.
* Patients are clinically predicted to be treated for more than 5 days (qSOFA and clinical assessment)

Exclusion Criteria:

* History of suffering from neuromuscular disease and or diaphragmatic malformations
* Used non-invasive ventilation before starting to use mechanical ventilation
* History of tracheostomy
* Patients admitted to ICU within 12 months before this study

Primary outcomes:
measure: Level of Prealbumin Serum
timeFrame: 5 days
measure: Ratio of Neutrophil to Lymphocyte
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Indonesia University
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Rudyanto Sedono
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li C, Li X, Han H, Cui H, Wang G, Wang Z. Diaphragmatic ultrasonography for predicting ventilator weaning: A meta-analysis. Medicine (Baltimore). 2018 Jun;97(22):e10968. doi: 10.1097/MD.0000000000010968.
citation: Flevari A, Lignos M, Konstantonis D, Armaganidis A. Diaphragmatic ultrasonography as an adjunct predictor tool of weaning success in patients with difficult and prolonged weaning. Minerva Anestesiol. 2016 Nov;82(11):1149-1157. Epub 2016 Jul 12.
citation: Conti G, Montini L, Pennisi MA, Cavaliere F, Arcangeli A, Bocci MG, Proietti R, Antonelli M. A prospective, blinded evaluation of indexes proposed to predict weaning from mechanical ventilation. Intensive Care Med. 2004 May;30(5):830-6. doi: 10.1007/s00134-004-2230-8. Epub 2004 Mar 20.
citation: Sellares J, Ferrer M, Cano E, Loureiro H, Valencia M, Torres A. Predictors of prolonged weaning and survival during ventilator weaning in a respiratory ICU. Intensive Care Med. 2011 May;37(5):775-84. doi: 10.1007/s00134-011-2179-3. Epub 2011 Mar 4.
citation: Khan J, Harrison TB, Rich MM. Mechanisms of neuromuscular dysfunction in critical illness. Crit Care Clin. 2008 Jan;24(1):165-77, x. doi: 10.1016/j.ccc.2007.10.004.