Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation

NCT03608332 | Completed

• 1 other identifier: DUS in weaning
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)

Conditions

Diaphragmatic Ultrasound in Weaning

Outcome Measures

Primary Outcomes (1)

• Success rate of weaning from mechanical ventilation in both groups

  (The trial will be considered a successful weaning trial if the patient passed 48 hours without the need for neither invasive nor non-invasive ventilation)

  48 Hours after weaning

Secondary Outcomes (3)

• • Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables

  baseline

• • Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction

  baseline

• • Number of weaning trials prior to inclusion in the study

  baseline

Study Arms (2)

Group S

NO INTERVENTION

weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:- * Resolution of acute phase of disease for which patient was intubated * Adequate cough * Absence of excessive tracheobronchial secretions B) Objective criteria:- * Adequate oxygenation:PaO2\>60mmHg with PEEP\<8,SaO2\>90%,FIO2 \<0.5,PaO2/FIO2\>200 * Respiratory rate \<30 * PH and PaCO2 appropriate for patients' baseline respiratory status * Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia * HR\<140 beats/minute * Patient is arousable or Glasgow coma scale (GCS)\>13

Group SD

EXPERIMENTAL

weaning readiness will be evaluated with the following criteria:- A) Clinical assessment:- * Resolution of acute phase of disease for which patient was intubated * Adequate cough * Absence of excessive tracheobronchial secretions B) Objective criteria:- * Adequate oxygenation:PaO2\>60mmHg with PEEP\<8,SaO2\>90%,FIO2 \<0.5,PaO2/FIO2\>200 * Respiratory rate \<30 * PH and PaCO2 appropriate for patients' baseline respiratory status * Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia * HR\<140 beats/minute * Patient is arousable or Glasgow coma scale (GCS)\>13 C) Ultrasound criteria:- • Diaphragmatic excursion \>11 mm

Device: diaphragmatic ultrasound

Interventions

diaphragmatic ultrasound DEVICE

Diaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6).

Group SD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patients intubated for more than 48 hours who are ready for weaning

You may not qualify if:

• Age \< 18 years
• surgical dressings over the right lower rib cage which would preclude ultrasound examination
• patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic injury and diaphragmatic surgery
• patients with neuromuscular diseases ( myasthenia gravis ,Muscular dystrophies ,Multiple sclerosis and Amyotrophic lateral sclerosis)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University-Manial

Cairo, Egypt

Location

Related Publications (11)

• El-Khatib MF, Bou-Khalil P. Clinical review: liberation from mechanical ventilation. Crit Care. 2008;12(4):221. doi: 10.1186/cc6959. Epub 2008 Aug 6.

  PMID: 18710593 BACKGROUND

• MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.

  PMID: 11742959 BACKGROUND

• Fagon JY, Chastre J, Hance AJ, Montravers P, Novara A, Gibert C. Nosocomial pneumonia in ventilated patients: a cohort study evaluating attributable mortality and hospital stay. Am J Med. 1993 Mar;94(3):281-8. doi: 10.1016/0002-9343(93)90060-3.

  PMID: 8452152 BACKGROUND

• Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

  PMID: 7823995 BACKGROUND

• Heunks LM, van der Hoeven JG. Clinical review: the ABC of weaning failure--a structured approach. Crit Care. 2010;14(6):245. doi: 10.1186/cc9296. Epub 2010 Dec 8.

  PMID: 21143773 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

  PMID: 21705883 BACKGROUND

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

  PMID: 24949192 BACKGROUND

• DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

  PMID: 24365607 BACKGROUND

• Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.

  PMID: 9927366 BACKGROUND

• Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.

  PMID: 15249460 BACKGROUND

Study Officials

• ahmed mohamed moukhtar, MD

  professor of anesthesiology cairo university

  PRINCIPAL INVESTIGATOR

• waleed ibrahim Hamimmy, MD

  professor of anesthesiology cairo university

  PRINCIPAL INVESTIGATOR

• akram shahat Eladawy, MD

  assistant professor of anesthesiology cairo university

  PRINCIPAL INVESTIGATOR

• ahmed muhamed lotfy, MD

  lecturer of anesthesiology cairo university

  PRINCIPAL INVESTIGATOR

• mina adolf helmy, MSc

  assistant lecturer of anesthesiology cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: April 30, 2018
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

EG (1)