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CompletedNCT03983044DEPTUpdated Jan 23, 2020

Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery

An observational study in Intensive Care Unit and Cardiac Surgery, sponsored by Centre Chirurgical Marie Lannelongue. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Centre Chirurgical Marie Lannelongue · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intensive Care Unit
  • Cardiac Surgery

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Keywords

  • cough evaluation
  • intensive care unit
  • utrasound evaluation
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 44 is below the median of 94 across 75 observational studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant patient
  • Recent history of stroke(\<6 months )
  • Minor patient
  • Neurological disorder (Alzheimer's disease, delirium, confusion)
  • Emphysemal patient
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

  2. 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.

    Time frame: 48 hours

07

Study locations

1 site
  • Centre Chirurgical Marie Lannelongue
    Le Plessis-Robinson, 92350, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03983044
Lead sponsor
Centre Chirurgical Marie Lannelongue
Responsible party
Sponsor
First posted
Jun 12, 2019
Start date
Oct 9, 2018
Primary completion
Jul 9, 2019
Completion
Jul 9, 2019
Last update
Jan 23, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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