4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery (DEPT)

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

Study Description
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.


Condition or disease
Intensive Care Unit Cardiac Surgery

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow
Actual Study Start Date : October 9, 2018
Actual Primary Completion Date : July 9, 2019
Actual Study Completion Date : July 9, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. parietal ultrasound [ Time Frame: 48 hours ]
    compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.

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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
Criteria

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:

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

Locations
Layout table for location information
France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Tracking Information
First Submitted Date June 6, 2019
First Posted Date June 12, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date October 9, 2018
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
  • parietal ultrasound [ Time Frame: 48 hours ]
    compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.
  • peak expiratory flow rate [ Time Frame: 48 hours ]
    compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery
Official Title Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
Condition
  • Intensive Care Unit
  • Cardiac Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2019)
44
Original Estimated Enrollment Same as current
Actual Study Completion Date July 9, 2019
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Pregnant patient
  • Recent history of stroke(<6 months )
  • Minor patient
  • Neurological disorder (Alzheimer's disease, delirium, confusion)
  • Emphysemal patient
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03983044
Other Study ID Numbers 2018-A01114-51
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Chirurgical Marie Lannelongue
Study Sponsor Centre Chirurgical Marie Lannelongue
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Chirurgical Marie Lannelongue
Verification Date May 2019