NCT04014439

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

July 8, 2019

Last Update Submit

December 30, 2019

Conditions

Keywords

diaphragm thicknessneutrophil to lymphocyte ratiomechanical ventilation

Outcome Measures

Primary Outcomes (2)

  • Level of Prealbumin Serum

    5 days

  • Ratio of Neutrophil to Lymphocyte

    5 days

Study Arms (2)

Normal Diaphragm

Diaphragm thickness is 2 mm or more

Diagnostic Test: Ratio of Neutrophil to LymphocyteDiagnostic Test: Level of Prealbumin Serum

Thinning Diaphragm

Diaphragm thickness is less than 2 mm

Diagnostic Test: Ratio of Neutrophil to LymphocyteDiagnostic Test: Level of Prealbumin Serum

Interventions

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.

Normal DiaphragmThinning Diaphragm

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.

Normal DiaphragmThinning Diaphragm

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia University

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • 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 Officials

  • Rudyanto Sedono

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

September 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations