Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome

NCT04825509 | Completed

• 1 other identifier: Diaphragm Ultrasound
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit

Conditions

Weaning Failure; Sepsis

Keywords

Diaphragm ultrasound; Weaning predictor

Outcome Measures

Primary Outcomes (1)

• Successful extubation

  extubation success or failure will depend on patient needs to MV during spontaneous breathing trial (SBT), or invasive or non-invasive ventilation within 48 hours after extubation according to: respiratory rate\>35/min, increased work of breathing, O2 saturation \<90% with fraction of inspired oxygen (FIO2)\>50%, new arrhythmias, increased heart rate\>20% or more than 140b/min, drop of 20 millimetre mercury (mmHg) or rise of 30 mmHg systolic blood pressure, increased systolic blood pressure \>180 mmHg in normotensive patient, change of 10 mmHg diastolic blood pressure and deterioration of blood gases value

  from start of SBT till 48 hours after extubation

Secondary Outcomes (1)

• need for tracheostomy

  From start of SBT for 21 days

Study Arms (2)

Successful weaning group

Patients will be in this group according to primary outcome, if they will succeed spontaneous breathing trial for 120 minutes and will be extubated successfully without need for invasive or non-invasive ventilation for 48 hours

Device: Ultrasound

Weaning failure group

Patients will be in this group according to primary outcome, if they will fail spontaneous breathing trial or extubation within 48 hours Weaning failure will be considered if: * Patients will need MV during spontaneous breathing trial within 120 minutes, or * patients will need invasive or non-invasive ventilation within 48 hours

Device: Ultrasound

Interventions

Ultrasound DEVICE

Diaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines. Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line. Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line.

Successful weaning group; Weaning failure group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients will be intubated (for 2 - 7 days) and ready for weaning process. They will undergo diaphragmatic ultrasound on spontaneous breathing pattern on T-piece connected to 8L/min O2 with subsequent outcome either successful weaning or failed weaning

You may qualify if:

• Patients of both sexes, aging 18 - 60 years after written informed consent
• Patients with sepsis on admission according to the new sepsis definition in 2016 (life-threatening organ dysfunction due to a dysregulated host response to infection)
• Hemodynamically stable without or with low dose support
• Patients on mechanical ventilation for at least 48 hours and not more than 1 week
• Patients ready for start of weaning protocol, fully conscious, on continuous positive airway pressure (CPAP) mode with positive end expiratory pressure (PEEP) 3-5 Centimetre water (CmH2O), Pr. Supp. \<15 CmH2O, Fio2 less than 60%, Respiratory rate less than 35 breath/min, partial oxygen pressure (PO2)/FIO2 \>200, Rapid Shallow Breathing Index (RSBI) is less than 105

You may not qualify if:

• Patients aged less than 18 years or more than 60 years old
• Patients in septic shock, hemodynamically unstable or on high dose support
• Patients on mechanical ventilation for more than 1 week or less than 48 hours
• Patients not ready for start of weaning from mechanical ventilation
• Patients with neuromuscular disorders
• Pregnant females in the second and third trimester, patients with tense ascites or morbidly obese with body mass index more than 40 kg/m2

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, 11591, Egypt

Location

Related Publications (3)

• Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.

  PMID: 28864053 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

• Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.

  PMID: 33309837 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mohamed Saad

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: April 18, 2021
• Primary Completion: October 17, 2021
• Study Completion: November 1, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)