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NCT Number: NCT04825509

Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome

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

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Key information

Conditions

Weaning Failure Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University Hospital

Cairo, 11591, Egypt

About this study

After being informed about the study and giving written informed consent, Intubated and mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness (DT) and calculate diaphragm thickness fraction (DTF):

DT during inspiration - DT during expiration / DT during expiration

According to weaning outcome, patients will be divided into 2 groups:

  • Successful weaning group
  • Weaning failure group

By statistical analysis we will define the cut off value and area under curve (AUC) for DE and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for weaning from MV or not

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Successful extubation

    Time frame: from start of SBT till 48 hours after 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

Secondary outcomes

  1. need for tracheostomy

    Time frame: From start of SBT for 21 days

    We will check patient need for tracheostomy since start of weaning process for 21 days and the indication for tracheostomy, if due to prolonged intubation or other causes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome in Mechanically Ventilated Patients With Sepsis in Intensive Care Unit

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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