Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness

Relationship Between Neutrophil to Lymphocyte Ratio and Prealbumin Serum Levels With Diaphragm Thickness in Critical Patients

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Response
• Intervention / Treatment: Diagnostic test: Ratio of Neutrophil to Lymphocyte; Diagnostic test: Level of Prealbumin Serum

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Indonesia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Diaphragm; Diaphragm thickness is 2 mm or more	Diagnostic test: Ratio of Neutrophil to Lymphocyte; Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.; Diagnostic test: Level of Prealbumin Serum; Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
Thinning Diaphragm; Diaphragm thickness is less than 2 mm	Diagnostic test: Ratio of Neutrophil to Lymphocyte; Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.; Diagnostic test: Level of Prealbumin Serum; Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of Prealbumin Serum	5 days
Ratio of Neutrophil to Lymphocyte	5 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Rudyanto Sedono, Indonesia University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; diaphragm thickness; neutrophil to lymphocyte ratio
• Other Study ID Numbers: IndonesiaUAnes037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No