Checking the efficacy of lung and diaphragm ultrasonography in weaning of patients from mechanical ventilation in intensive care settings

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/03/041133
• Lead Sponsor: Himalayan Institute of Medical Sciences

Brief Summary

Almost 20% of the patients in the intensive care unit (ICU) on mechanical ventilation (MV), experience difficult and prolonged weaning, even after thorough observation and application of the weaning criteria. Conventional methods like regular assessment of breathing frequency, minute ventilation, and negative inspiratory force have little impact in improving the decision of timing of successful extubation. RSBI has been accepted as a successful guide for correct timing of extubation with spontaneous breathing trials.

Diaphragmatic dysfunction being a common cause of weaning failure, needs to be assessed during weaning . Ultrasonography has emerged as a promising solution to overcome failed extubations and has been extensively studied over the past few years.  USG can easily allow direct visualization of the diaphragm and help us in assessing its contractility and functional efficacy, thus leading to better prediction of weaning outcome and post extubation distress and its cause.  Thus, we can gain reassurance over and above the traditional indices for successful weaning.

We formulated a hypothesis that ultrasound guided weaning of a patient from mechanical ventilation may decrease the chances of reintubation. This study aims to prospectively investigate the value of lung and diaphragmatic ultrasonography in the prediction of weaning outcomes and chances of reintubation in patients being weaned from mechanical ventilation and comparing them with the traditional indices for weaning, like RSBI.

**SAMPLE SIZE:** 100

With reference to a previous study(1), the prevalence was taken as 67%.

The formula for calculated sample size is givenbelow:

n = (Z 1- α/2 )2 x P(1-P)

d2

 = (1.96)2 x 0.67(1- 0.67)

0.01

= 84.937 =85

Where, Zα/2 isthe critical value of the Normal distribution at α/2 (e.g., α is 0.1 and thecritical value is 1.96).

85 is the calculatedminimum sample size.

**METHODS:**

·              All patients selected will be the ones already on mechanical ventilationvia an endotracheal tube in situ.

·               Patients will be put to a SBTwhen they meet the weaning criteria. Patients will be put on PressureSupport/CPAP trial for half an hour. Failure of the weaning process shall be defined as a failedSBT or the need for reintubation/ NIV (non-invasive ventilatory support) within48 hours following extubation , so all the patients included in the studywill be observed for 48 hours after the SBT. The following weaning indices willbe recorded for all patients during the SBT: Tidal volume (TV), Respiratoryrate (RR), ABG: Po2, Spo2 % and Po2/Fio2, Rapid shallow breathing index: (RSBI(f/VT) = Respiratory rate/tidal volume.

·              Bedside ultrasound will be performed 20 minutes after initiation of SBTby a critical care consultant in the ICU, well versed with the use of bedsidelung and abdominal ultrasonography and its interpretation. Initial USG will be doneimmediately after putting the patient on SBT to check the anatomy of thediaphragm and to rule out patients according to exclusion criteria. This willbe followed by a complete diaphragmatic and lung USG after 20 minutes ofinitiation of SBT. Three readings shall be recorded for each USG index and anaverage value of the three recordings shall be used further.  After the extubation, all patients will bemonitored for failed or successful weaning. Weaning will be consideredsuccessful if the patient did not require noninvasive or invasive ventilationwithin 48 hours of extubation. At the end of the study, thepatients will be divided into two groups: successful group and failed group (re‑intubation within 48 h after extubation)according to their response to weaning trials.

TheDiaphragmatic Excursion, Diaphragmatic Thickness Fraction %, diaphragmic contraction (DC), and LUSm( modified Lung Ultrasound Score) score measurements will becollected for each group and then will be correlated with RSBI.

·

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-15
• Study Start: 2022-03-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age between 18-65 years, 2) Patients who have been in an intubated state since a minimum of 48 hours, 3) Excessive tracheobronchial secretions not present, 4) The underlying critical illness (their reason for intubation) must have been resolved, 5) Patients fulfilling the criteria of conventional methods for weaning from mechanical ventilation.

Exclusion Criteria

1. Hemodynamic instability requiring vasopressors, 2) Gas exchange impairment requiring positive end- expiratory pressure (PEEP) >10 cmH2O and/or FIO2 > 50% to obtain a PaO2 > 60 mmHg, 3) Pressure support (PS) level > 20 cmH2O, 4) Deep sedation, 5) History of chronic obstructive pulmonary disease, neuromuscular disease, anatomical malformation of the diaphragm or use of muscle paralyzing agents, aminoglycosides and corticosteroids, 6) Pneumothorax or pneumomediastinum, increased intra-abdominal pressure, 7) Aseptic dressings over the chest that can hamper the process of ultrasonography.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Sensitivity and specificity of USG indices as predictors of weaning outcome.	To check if patient got reintubated within 48 hours post extubation
2.Positive predictive value (PPV), Negative predictive value (NPV) and diagnostic accuracy of USG indices as predictors of weaning outcome.	To check if patient got reintubated within 48 hours post extubation

Secondary Outcome Measures

Name	Time	Method
1.Comparison of traditional indices such as RSBI with USG indices as predictors of difficult weaning	checking for reintubation within 48 hours after extubation

Trial Locations

Locations (1)

Himalayan institute of medical sciences; 🇮🇳 Dehradun, UTTARANCHAL, India

Himalayan institute of medical sciences

🇮🇳Dehradun, UTTARANCHAL, India

Dr Sonika Agarwal

Principal investigator

6396918163

sonikakatiyar@srhu.edu.in