Diaphragmatic and Pulmonary US for Extubation Success Prediction

NCT02799056 | Completed

• 1 other identifier: NM16-00003
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess whether the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit.

Conditions

Airway Extubation

Keywords

Airway Extubation; Ultrasonography; Ventilator Weaning

Outcome Measures

Primary Outcomes (1)

• Extubation success

  The investigators consider successful extubation when the patient does not require reintubation within 72 hours of its extubation

  72 h after extubation

Interventions

Thoracic ultrasound DEVICE

The ultrasound will be performed using the ultrasound system GE Logiq XP equipped with a linear probe of 10 MHz. The diaphragm is visualized as two parallel echogenic lines at the eighth intercostal space in the mid-axillary line. The images will be captured during the inspiratory and expiratory tidal volume to and during maximum inspiration and expiration. Each image will be frozen in B mode and the diaphragm thickness will be measured from the center line pleural half the peritoneal line. The fraction of diaphragmatic thickening it is calculated by the formula: diaphragmatic thickness at the end of inspiration - thickness to diaphragmatic at the end of exhalation / diaphragmatic thickness at the end of exhalation x 100. The number of areas with lines B also will be measured.

Eligibility Criteria

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

Study Population

18 years or older patients, hospitalized in medical or surgical intensive care unit of the University Hospital "Dr. José E. González "from 1 may 2016 until the sample size is completed and who have successful spontaneous ventilation trial as part of routinely applied extubation protocol.

You may qualify if:

• years of older
• Hospitalized in medical or surgical intensive care unit
• Successful spontaneous ventilation trial

You may not qualify if:

• Patients reintubated after a first failure after extubation
• Injuries to prevent conduct ultrasound
• Pregnancy
• History of neuromuscular disease
• Brain injury that prevented adequate protection of the airway (Glasgow Coma Scale \<8)
• Unilateral or bilateral Pneumothorax
• Presence of chest tube in right hemothorax
• Right subphrenic abscess
• Known uni- or bilateral phrenic nerve injury
• Unilateral or bilateral diaphragmatic Paralysis
• Unwillingness of the patient or guardian to participate in the study

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

UANL University Hospital

Monterrey, Nuevo León, 64000, Mexico

Location

Related Publications (17)

• McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.

  PMID: 23215559 BACKGROUND

• Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.

  PMID: 8948561 BACKGROUND

• Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.

  PMID: 2023603 BACKGROUND

• Huaringa AJ, Wang A, Haro MH, Leyva FJ. The weaning index as predictor of weaning success. J Intensive Care Med. 2013 Nov-Dec;28(6):369-74. doi: 10.1177/0885066612463681. Epub 2012 Oct 22.

  PMID: 23753219 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.

  PMID: 18403664 BACKGROUND

• Silva S, Biendel C, Ruiz J, Olivier M, Bataille B, Geeraerts T, Mari A, Riu B, Fourcade O, Genestal M. Usefulness of cardiothoracic chest ultrasound in the management of acute respiratory failure in critical care practice. Chest. 2013 Sep;144(3):859-865. doi: 10.1378/chest.13-0167.

  PMID: 23670087 BACKGROUND

• Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jorres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19(1):36. doi: 10.1186/s13054-015-0756-5.

  PMID: 25656060 BACKGROUND

• Mongodi S, Via G, Bouhemad B, Storti E, Mojoli F, Braschi A. Usefulness of combined bedside lung ultrasound and echocardiography to assess weaning failure from mechanical ventilation: a suggestive case*. Crit Care Med. 2013 Aug;41(8):e182-5. doi: 10.1097/CCM.0b013e31828e928d.

  PMID: 23863255 BACKGROUND

• Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

  PMID: 22584759 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

• Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  PMID: 19017880 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

• 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

• 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

• Criner GJ. Measuring diaphragm shortening using ultrasonography to predict extubation success. Thorax. 2014 May;69(5):402-4. doi: 10.1136/thoraxjnl-2013-204920. No abstract available.

  PMID: 24727579 BACKGROUND

• Diederich S, Link TM, Zuhlsdorf H, Steinmeyer E, Wormanns D, Heindel W. Pulmonary manifestations of Hodgkin's disease: radiographic and CT findings. Eur Radiol. 2001;11(11):2295-305. doi: 10.1007/s003300100866.

  PMID: 11702175 BACKGROUND

Study Officials

• Julio E González, MD

  Universidad Autónoma de Nuevo León

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

ME (1)