NCT03983044

Brief Summary

Weaning from mechanical ventilation represents 50% of the time spent under mechanical ventilation (1). The risk factors identified in the failure to wean from mechanical ventilation are:

  • left heart dysfunction with LVEF \< 30%.
  • an ineffective cough
  • presence of resuscitation neuromyopathy
  • mechanical ventilation time \>7 days
  • presence of a delirium
  • age \>65 years old
  • abundant bronchial secretion
  • presence of underlying lung pathology An ineffective cough is found in 40% of patients requiring reintubation. However, cough assessment is most often approximate, based on a subjective assessment of cough strength by asking the patient to cough spontaneously on his or her tube). The objective evaluation of cough is based on the measurement of the peak expiratory flow rate at cough, commonly referred to as peak expiratory flow rate at cough (PEFD), the patient is asked to take a deep breath and then cough as hard as possible. Subjective cough assessment does not predict the occurrence of ventilatory withdrawal failure. Conversely, all studies that objectively assessed the strength of cough before extubation by measuring the PEFD found a significant association with the outcome of extubation: a low PEFD increases the risk of extubation failure by a factor of 5 to 9. The investigators hypothesize that the increase in parietal abdominal muscle contraction obtained by using a non-invasive ultrasound method indicates an effective cough. Conversely, an ineffective cough can be detected by this simple ultrasound criterion, which can be performed at the patient's bedside and extrapolated to all intensive care units equipped with an ultrasound scanner. This evaluation will be carried out before extubation: during the spontaneous ventilation test on a tube in a half-seated position (\>45°) and within 24 hours after extubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 9, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
Last Updated

January 23, 2020

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

June 6, 2019

Last Update Submit

January 21, 2020

Conditions

Keywords

cough evaluationintensive care unitutrasound evaluation

Outcome Measures

Primary Outcomes (2)

  • parietal ultrasound

    compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.

    48 hours

  • peak expiratory flow rate

    compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.

    48 hours

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.

You may qualify if:

  • Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.

You may not qualify if:

  • Pregnant patient
  • Recent history of stroke(\<6 months )
  • Minor patient
  • Neurological disorder (Alzheimer's disease, delirium, confusion)
  • Emphysemal patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 12, 2019

Study Start

October 9, 2018

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

January 23, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations