The Role of Diaphragmatic Ultrasound as a Predictor of Extubation From Mechanical Ventilation

NCT ID: NCT05063526

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-11-01

Brief Summary

Aim: To evaluate real-time ultrasound in the evaluation of diaphragmatic thickening, thickening fraction and or excursion to predict extubation outcomes. The investigators aimed to compare these parameters with other traditional weaning measures.

Detailed Description

The diaphragm is an important respiratory muscle and dysfunction is very common in patients receiving mechanical ventilation. Diaphragm fatigue occurs even in patients who successfully pass the Spontaneous Breathing Test (SBT). Interrupting ventilation too early can lead to increased cardiovascular and respiratory pressure (CO2).retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in liberation from mechanical ventilation also can be deleterious. Complications such as ventilator-associated pneumonia and ventilator-induced diaphragm atrophy can be seen with short periods of mechanical ventilation thereby prolonging mechanical ventilation. As SBT monitoring is insensitive to detect early signs of load-capacity imbalance. The evaluation of the diaphragmatic thickening fraction (DTF) may be also helpful to assess diaphragmatic function and its contribution to respiratory workload. Ultrasound can be used to detect the deflection of the diaphragm, which helps to identify patients with diaphragm dysfunction

Conditions

Diaphragm Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group B

40 patients who are mechanically ventilated due to pulmonary disease at respiratory ICU had their diagnosis as follows: 21 (53%) had COPD, 8 (20%) had asthma, 5 (13%) had bronchiectasis, 5 (13%) had pneumonia and

1 (3%) had viral influenza H1N1. Out of group B patients, 11 patients (13.75%) had failed weaning, of which 6 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 3 patients were re-intubated and 2 patients died.

ultrasound

Intervention Type: DEVICE

ultrasound on diaphragm

Group A

40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU had their diagnosis as follows: 24 (60%) had congestive heart failure, 4 (10%) had diabetes mellitus, 4 (10%) had sepsis other than pneumonia, 2 (5%) had epilepsy, 2 (5%) had embolic hemiplegia, and 4 (10%) had chronic renal failure. Out of group A patient, 9 patients (11.25%) had failed weaning of which 4 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 2 patients were reintubated and 3 patients died.

ultrasound

Intervention Type: DEVICE

ultrasound on diaphragm

control group.

40 patients Chronic obstructive pulmonary disease (COPD) from Outpatient Clinic

ultrasound

Intervention Type: DEVICE

ultrasound on diaphragm

Interventions

ultrasound

ultrasound on diaphragm

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria.

1. positive end-expiratory pressure (PEEP) ≤ 5 cm H2O.

2. Fraction of inspired oxygen (FiO2) < 0.5.

3. respiratory rate (RR) < 30 breaths/min.

4. rapid shallow breathing index < 105, PaO2/FiO2 > 200.

• Age< 65 years.

Exclusion Criteria

• Age<18 years.
• Patient with history of plural effusion, trauma to chest and history of mechanical ventilation for < 6 months.
• patient with neuromuscular diseases affect diaphragm .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Aelgharib Ahmed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randa S Mohamed, professor

Role: STUDY_DIRECTOR

Benisuef unviresity

Locations

Beni-suef

Banī Suwayf, Mequbal, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24949192 (View on PubMed)

Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.

Reference Type: BACKGROUND

PMID: 23364680 (View on PubMed)

Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

Reference Type: BACKGROUND

PMID: 27112953 (View on PubMed)

Umbrello M, Formenti P. Ultrasonographic Assessment of Diaphragm Function in Critically Ill Subjects. Respir Care. 2016 Apr;61(4):542-55. doi: 10.4187/respcare.04412. Epub 2016 Jan 26.

Reference Type: BACKGROUND

PMID: 26814218 (View on PubMed)

Other Identifiers

FMBSUREC/05012020/Ahmed

Identifier Type: -

Identifier Source: org_study_id