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Postoperative Pulmonary ComplicationsDPOCUSNCT03688724

Perioperative Diaphragm Point of Care Ultrasound

An observational study of Postoperative Pulmonary Complications and Diaphragm, run by Hospital General Universitario de Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 in both hemidiaphragms by ultrasound (using Diaphragm Thickening Fraction), which allows to obtain the real incidence of Hemidiaphragm palsy in… Read more about this study

Who is it for?
Ages 18 years and older
How many people
65 participants
Where
1 siteSpain
Study dates
15 Oct 2018to 1 May 2021
How long will I take part?
2 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients scheduled for upper limb surgery

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital General Universitario de Valencia

    Valencia, 46003

Other trials in Spain

About this study

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

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 in both hemidiaphragms by ultrasound (using Diaphragm Thickening Fraction), which allows to obtain the real incidence of Hemidiaphragm palsy in these patients, and estimate the perioperative evolution of both hemidiaphragms.

Hemidiaphragm palsy after brachial plexus block above the clavicle (BPBAC) is frequent, but few patients develop postoperative pulmonary complications (PPC). Little attention has been paid to the contralateral hemidiaphragm as part of the global diaphragmatic function. After BPBAC, global diaphragm function reduces due to ipsilateral hemidiaphragm reduction, but less than expected due to the increase in the contralateral hemidiaphragm function. As a part of the diaphragm function, the contralateral hemidiaphragm function plays a relevant role in the appearance of PPC.

Read the detailed description

INTRODUCTION Shoulder surgery is known to be a particularly painful stimulus. Perioperative analgesia using brachial plexus block by injection above the clavicle (BPBAC) for shoulder surgery is the standard of care 1,2.

Up to date, ipsilateral diaphragmatic paresis after BPBAC is still very frequent, but few patients develop postoperative pulmonary complications (PPC), and most of them are mild8. There is much concern in avoiding ipsilateral hemidiaphragmatic paralysis to reduce PPC. Little attention has been paid to the contralateral diaphragm and the global diaphragmatic function formed by both hemidiaphragms (the ipsilateral and the contralateral to the BPBAC).

A meticulous study of perioperative diaphragm evolution is needed to answer why some patients after BPBAC develop PPC and others do not.

OUTCOMES The primary objective was to examine the evolution of perioperative hemidiaphragm function with ultrasound (ipsilateral and contralateral) when using BPBAC following shoulder surgery.

the hypothesis is that despite frequent acute ipsilateral hemidiaphragm paralysis after BPBAC, the contralateral hemidiaphragm function increases and preserves global diaphragmatic function in most patients.

METHODS A prospective observational cohort study evaluating perioperative (preoperative and postoperative) diaphragm point-of-care ultrasound (D-POCUS) at an academic tertiary hospital in Spain. Adults undergoing shoulder surgery with planned BPBAC (ISB or SCB) will be eligible for inclusion. Patients planned for not receive BPBAC for any reason will be exclude.

Thickening diaphragm fraction (TF) and diaphragm excursion (DE) were measured in both hemidiaphragms before BPBAC (at the preoperative time) and within 30 min after surgery (at the postoperative time, at least 1 hour after BPBAC).

All measures will be repeated three times in each patient and by the same member of the research team to reduce intra-observer and inter-observer variability. In addition, he will be blinded to the side on which the BPBAC will be performed.

TF was calculated using the following formula: TF = (Tdi-Tde)/Tde x100 (%). TF ipsilateral was the TF measured in the hemidiaphragm ipsilateral to the BPBAC. TF contralateral was the TF measured in the hemidiaphragm contralateral to the BPBAC. TFglobal was the sum of both hemidiaphragm TF to reflect the global diaphragm function. It was calculated using the following formula: (TF Global = (TF ipsilateral + TF contralateral). DE was measured in mm.

Baseline characteristics of participants were collected, including age, gender, comorbidities, respiratory rate (RR), basal SpO2 (Oxygen saturation measured by pulse oximeter), respiratory symptoms, and ARISCAT scale . also data were collect during perioperative, related to BPBAC (loco-regional technique, local anesthetic, concentration, volume of injection); related to intraoperative management (hypnotics, morphic and blocking neuromuscular agents used); and related to postoperative (Train-Of-Four(TOF) scale, visual analog scale (VAS) Pain, RR, SpO2, fraction of inspired oxygen (FiO2), SpO2/FiO2, existence of postoperative pulmonary complications (PPC) ). PPC is defined as the occurrence of dyspnea, tachypnea (RR >20% of preoperative RR), SpO2 <90%, or SpO2/FiO2 <315.

Statistical Analyses Continuous variables will be reported as medians with their interquartile range [IQR] or means with standard deviations (SD) where applicable, and categorical variables as counts and percentages. Group comparisons of continuous variables will be made using the Student t-test or Mann-Whitney U test, or Wilcoxon rank-sum test as appropriate. Chi-square test, Fisher exact test, and Kruskal-Wallis test will be used where appropriate for categorical variables. Analyses will be performed using IBM SPSS Statistics for Windows, Version 24.0 (IBM Corp, Armonk, NY).

SAMPLE SIZE

The sample size was calculated using Gpower 3.1. An effect size of 0.48 was calculated based on the difference between two dependent means (matched pairs) obtained on previous pilot study data. The occurrence of TFcontralateral variation before and after BPBAC was 12±30. A sample size of 59 patients was required to detect a 20% of TFcontralateral variation with 95% power and a two-sided alpha of 0.05. an increase of 10% on sample size was applied.

TOTAL n= 65 patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contralateral Diaphragm function change

    Thickening fraction (%) change of contralateral hemidiaphragm Before-After Brachial plexus Block

    Measured: day of surgery (1 hour before surgery starts and 1 hour after surgery ends)

Secondary outcomes (3)
  1. Ipsilateral Diaphragm function change

    Thickening fraction (%) of ipsilateral hemidiaphragm to BPBAC

    Measured: day of surgery (1hour before surgery starts and 1hour after surgery ends)

  2. Incidence of Postoperative Pulmonary Complications

    we consider PPC (Dyspnea, oxygen saturation below 92%,PO2/FiO2<300, need for reintubation, high respiratory rate>22)

    Measured: postoperative 30 min after surgery at PACU(post anesthesia care unit)

  3. Incidence of contralateral hemidiaphragm increase after BPBAC.

    we consider Contralateral hemidiaphragm increase any Thickening Fraction at postoperative >Thickening Fraction at preoperative.

    Measured: POSTOPERATIVE 30 min after surgery at PACU (post anesthesia care unit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start15 Oct 2018
  3. Primary completion5 Mar 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
65 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688724
Sponsor's protocol ID
ROV-DPOCUS-2018-01
Acronym
DPOCUS
Status last verified
Jan 2022
First submitted
14 Sep 2018
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pulmonary Complications and Diaphragm, run by Hospital General Universitario de Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contralateral Diaphragm function change (time frame: day of surgery (1 hour before surgery starts and 1 hour after surgery ends)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.

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