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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04014439
Other study ID # IndonesiaUAnes037
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 1, 2019

Study information

Verified date December 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 17 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Indonesia Indonesia University Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. Epub 2004 Mar 20. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of Prealbumin Serum 5 days
Primary Ratio of Neutrophil to Lymphocyte 5 days
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