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Perioperative Diaphragm Point of Care Ultrasound (DPOCUS)

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ClinicalTrials.gov Identifier: NCT03688724
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Lucas Rovira, Hospital General Universitario de Valencia

Brief Summary:

It is a prospective observational study of a cohort of patients who underwent brachial plexus blockage above the clavicle, and in which diaphragmatic function is observed by ultrasound, which allows to obtain the real incidence of ventilatory failure in these patients, and estimate the cut-off point with greater sensitivity and specificity of the ultrasound values to predict the risk of the appearance of ventilatory failure.

Overall, the incidence of postoperative ventilatory failure is 3%. In those patients who suffer a reduction in ventilatory function after phrenic nerve block, this risk increases. Diaphragmatic ultrasound by evaluating the TF (thickening fraction of the diaphragm) and E (diaphragmatic excursion) has shown great sensitivity and specificity in predicting success in ventilatory weaning of patients under mechanical ventilation in the ICU.

This study assess perioperative diaphragmatic ultrasound (before and after surgery) as a diagnostic method, observing the incidence of ipsilateral hemidiaphragm blockade (greater than 90% according to previous published articles) and seeking to know the relative risk of suffering post-operative ventilatory failure in this cohort, observing the cut-off point of TF and E that allows to predict with greater sensitivity and specificity the risk of the appearance of ventilatory failure in case of ipsilateral hemidiaphragmatic block.


Condition or disease
Postoperative Respiratory Failure

Detailed Description:

Introduction: Globally, the incidence of Postoperative ventilatory failure (PVF ) is 3%. in patients with reduce ventilatory function due to phrenic nerve block PVF increases to 16% (data obtained from a pilot study not published). Diaphragmatic ultrasound by evaluating the TF (thickening fraction of the diaphragm) and DE (diaphragmatic excursion) has shown great sensitivity and specificity in predicting success in ventilatory weaning of patients under mechanical ventilation in the ICU. in the same way, the hypothesis of researchers is that Diaphragms ultrasound its also a useful tool to detect and predict patients at risk of develope PVF in case of hemidiaphragm palsy.

Sample size estimated: 124 patients RELATIVE RISK

Proportion exposed with study event (PVF after ISB 16%): 0,16 Proportion exposed without study event (global PVF 3%): 0,03 Relative risk to detect: 5,33 confidence level: 0,90 relative Precision : 0,6 Minimum SAMPLE SIZE: 124

we measure:

  1. Ecographic Diaphragm function measured 2 times, TF (thickening fraction) and DE (diaphragmatic excursion).

    • Measure 1 preoperative (before ISB and surgical procedure): it asses diaphragm function of both hemidiaphragms.
    • Measure 2 postoperative (after ISB and surgical procedure): it reasses diaphragm function of both hemidiaphragms.
  2. Incidence of Postoperative Ventilatory Failure PVF (defined by RR>22, or dyspnea or PO2/FiO2<300)

Hipotesis: Despite high incidence of hemidiaprhagm palsy after ISB, patients only develope Postoperative ventilatory faliure when Contralateral Hemidiaphragm is not healthy.

main outcomes: incidence of hemidiaphragm palsy and PVF after shoulder surgery with Interscalene block.

secondary outcomes:

  1. cut-off values of TF and DE to detect PVF(Sensibility and Specificity)
  2. cut-off values of TF and DE to predict risk of PVF

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Perioperative Diaphragm Point-of-care Ultrasound (D-POCUS) for the Detection of Blockage and the Prediction of Postoperative Ventilatory Failure in Patients Who Received Brachial Plexus Blockages Above the Clavicle
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. Incidence of Postoperative ventilatory failure [ Time Frame: postoperative 30 min at PACU(post anesthesia care unit) ]
    we consider PVF (Dyspnea, oxygen saturation below 92%,PO2/FiO2<300, need for reintubation, high respiratory rate>22)


Secondary Outcome Measures :
  1. Diaphragm ultrasound evaluation [ Time Frame: Preoperatively (before Interscalene block at PACU) ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms

  2. Diaphragm ultrasound evaluation [ Time Frame: Postoperatively 30 min at PACU ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for upper limb surgery
Criteria

Inclusion Criteria:

  • Patients scheduled for any type of surgery that requires a supraclavicular or interscalene block.

Exclusion Criteria:

  • Age <18 years
  • No locoregional blockade over the clavicular for any reason, allergy to local anesthetics, coagulopathy, clinical reason.
  • Rejection to enter the observational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688724


Contacts
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Contact: Lucas Rovira, PhD +34659276476 lucasrovira@gmail.com
Contact: pablo kot, MD pablokot@hotmail.com

Locations
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Spain
Hospital General Universitario de Valencia Recruiting
Valencia, Spain, 46003
Contact: Lucas Rovira, PhD    +34659276476      
Sub-Investigator: Pablo Kot, MD         
Sponsors and Collaborators
Hospital General Universitario de Valencia
Investigators
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Principal Investigator: Lucas Rovira, PhD HGUV
Additional Information:

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Responsible Party: Lucas Rovira, Principal Investigator, Hospital General Universitario de Valencia
ClinicalTrials.gov Identifier: NCT03688724    
Other Study ID Numbers: ROV-DPOCUS-2018-01
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases