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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05063526
Collaborator
(none)
120
1
22
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound

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

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Diaphragmatic Ultrasound as a Predictor of Successful Extubation From Mechanical Ventilation in Respiratory Intensive Care Unit
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

Device: ultrasound
ultrasound on diaphragm

control group.

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

Device: ultrasound
ultrasound on diaphragm

Outcome Measures

Primary Outcome Measures

  1. diaphragmatic ultrasound thickening [during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year]

    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

  2. diaphragmatic ultrasound thickening fraction [during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year]

    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

  3. diaphragmatic ultrasound excursion [during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year]

    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

Secondary Outcome Measures

  1. diaphragmatic ultrasound thickening fraction [Up to 48 hours on T-tube, through study completion, an average of 1 year]

    Differences in thickening fraction ( millimeter )between patients who are successfully and failed weaning .

  2. diaphragmatic ultrasound thickening [Up to 48 hours on T-tube, through study completion, an average of 1 year]

    Differences in diaphragm thickening(percentage% )between patients who are successfully and failed weaning .

  3. diaphragmatic ultrasound excursion [Up to 48 hours on T-tube, through study completion, an average of 1 year]

    Differences in diaphragm excursion ( centimeter) between patients who are successfully and failed weaning

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beni-suef Banī Suwayf Mequbal Egypt

Sponsors and Collaborators

  • Beni-Suef University

Investigators

  • Study Director: Randa S Mohamed, professor, Benisuef unviresity

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Aelgharib Ahmed, Principal Investigator, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT05063526
Other Study ID Numbers:
  • FMBSUREC/05012020/Ahmed
First Posted:
Oct 1, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 8, 2021