Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative Diaphragm Point of Care Ultrasound (DPOCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 14, 2018
First Posted Date September 28, 2018
Last Update Posted Date April 3, 2019
Actual Study Start Date September 14, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2018)
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)
Original Primary Outcome Measures
 (submitted: September 26, 2018)
Incidence of Posoperative 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)
Change History
Current Secondary Outcome Measures
 (submitted: September 27, 2018)
  • Diaphragm ultrasound evaluation [ Time Frame: Preoperatively (before Interscalene block at PACU) ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms
  • Diaphragm ultrasound evaluation [ Time Frame: Postoperatively 30 min at PACU ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms
Original Secondary Outcome Measures
 (submitted: September 26, 2018)
  • Diaphragm ultrasound evaluation [ Time Frame: Preoperatively (before Interscalenne block at PACU) ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms
  • Diaphragm ultrasound evaluation [ Time Frame: Postoperatively 30 min at PACU ]
    Thickening fraction (%) and Diaphragm excursion (mm) of both hemidiaphragms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perioperative Diaphragm Point of Care Ultrasound
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
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.

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
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients scheduled for upper limb surgery
Condition Postoperative Respiratory Failure
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 Recruiting
Estimated Enrollment
 (submitted: September 26, 2018)
124
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Lucas Rovira, PhD +34659276476 lucasrovira@gmail.com
Contact: pablo kot, MD pablokot@hotmail.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03688724
Other Study ID Numbers ROV-DPOCUS-2018-01
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Lucas Rovira, Hospital General Universitario de Valencia
Study Sponsor Hospital General Universitario de Valencia
Collaborators Not Provided
Investigators
Principal Investigator: Lucas Rovira, PhD HGUV
PRS Account Hospital General Universitario de Valencia
Verification Date April 2019