NCT04779463

Brief Summary

Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

February 27, 2021

Last Update Submit

February 27, 2021

Conditions

Keywords

mechanical ventilation, parasternal muscle thickness

Outcome Measures

Primary Outcomes (1)

  • the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials

    The primary outcome is to assess the change of the parasternal intercostal muscles thickness at end of expiration and end of inspiration to verify the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials.

    Before the start spontaneous breathing trial

Study Arms (1)

Mechanical Ventilated patients

All patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial.

Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indicies

Interventions

Parasternal intercostal muscles thickness ultrasound indicies includes: * Parasternal Intercostals Thickness Fraction. * Parasternal Intercostals Thickness at the End of Inspiration. * Parasternal Intercostals thickness at the End of Expiration.

Also known as: Diaphragmatic thickness
Mechanical Ventilated patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial (SBT).

You may qualify if:

  • Any patient invasively mechanically ventilated at least 24 hours on a pressure support mode who is clinically stable and ready to undergo a spontaneous breathing trial.
  • All patients will be:
  • Alert.
  • Afebrile.
  • Adequate cough with absence of excessive tracheobronchial secretion.
  • Fraction of inspired oxygen (FIO2) of \<50%.
  • PEEP ≤8 cmH2O.
  • PaO2/FiO2 \> 150.
  • pH ≥7.35 and ≤7.45.
  • Respiratory rate (RR) ≤35 breaths/min.
  • Hemodynamically stable in the absence of vasopressors.
  • Stable metabolic and endocrinal status.
  • Euglycemic state.
  • Adequate mentation (no sedation or stable neurologic patient).

You may not qualify if:

  • Diaphragmatic paralysis (detected by ultrasonography).Patients\&Methods. 6
  • Pregnant women.
  • Age: \>= 18 years.
  • Surgical dressings over measurement point which would preclude ultrasound exam.
  • Underweight patients (Body mass index \<18.5 kg/m2).
  • Morbidly obese patient (Body mass index ≥ 40 kg/m2).
  • Primary neuro-muscular diseases.
  • Central coditions with depressed central respiratory drive (encephalitis, and brainstem haemorrhage/ischaemia).
  • Repiratory conditions with reduced pulmonary compliance (interstitial lung disease, pulmonary hemorrhage, and diffuse pulmonary infiltrates) or reduced chest wall compliance (kyphoscoliosis).
  • Cardiac conditions with high risk of weaning induced pulmonary edema (congestive heart failure, cyanotic heart diease, pulmonary hypertension, and ischemic heart diease).
  • Addict patients.
  • Patients with psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

Study Officials

  • Wesameldin A Soltan, M.D.

    faculty of medicine, Menoufia University

    STUDY DIRECTOR

Central Study Contacts

Wesameldin A Soltan, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

June 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations