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

NCT05063526 | Completed DMC

• 1 other identifier: FMBSUREC/05012020/Ahmed
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Ultrasound

Outcome Measures

Primary Outcomes (3)

• diaphragmatic ultrasound thickening

  Right diaphragmatic ultrasound measurement thickening in millimeter was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images

  during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year

• diaphragmatic ultrasound thickening fraction

  Right diaphragmatic ultrasound measurement thickening fraction(percentage% ) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images

  during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year

• diaphragmatic ultrasound excursion

  Right diaphragmatic ultrasound measurement excursion( centimeter) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images

  during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year

Secondary Outcomes (3)

• diaphragmatic ultrasound thickening fraction

  Up to 48 hours on T-tube, through study completion, an average of 1 year

• diaphragmatic ultrasound thickening

  Up to 48 hours on T-tube, through study completion, an average of 1 year

• diaphragmatic ultrasound excursion

  Up to 48 hours on T-tube, through study completion, an average of 1 year

Study Arms (3)

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.

Device: ultrasound

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.

Device: ultrasound

control group.

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

Device: ultrasound

Interventions

ultrasound DEVICE

ultrasound on diaphragm

Group A; Group B; control group.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study was carried out on 40 patients who are mechanically ventilated due to pulmonary disease, 40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU and 40Chronic obstructive pulmonary disease (COPD) patients from Outpatient Clinic serving as controls at Embaba Chest Hospital. Cairo, Egypt during a period from January 2018 to November 2019. Written informed consent was obtained from all patients prior to enrollment according to approval at the local committee of Beni-suef University Hospital.

You may qualify if:

• Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria.
• positive end-expiratory pressure (PEEP) ≤ 5 cm H2O.
• Fraction of inspired oxygen (FiO2) \< 0.5.
• respiratory rate (RR) \< 30 breaths/min.
• rapid shallow breathing index \< 105, PaO2/FiO2 \> 200.
• Age\< 65 years.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef

Banī Suwayf, Mequbal, Egypt

Location

Related Publications (4)

• 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

• 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.

  PMID: 23364680 BACKGROUND

• 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.

  PMID: 27112953 BACKGROUND

• 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.

  PMID: 26814218 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Randa S Mohamed, professor

  Benisuef unviresity

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 1, 2021
• Study Start: January 1, 2018
• Primary Completion: January 1, 2018
• Study Completion: November 1, 2019
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

EG (1)