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.
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
- Conditions the study is for
- Postoperative Pulmonary Complications, Diaphragm, Brachial Plexus Block
- 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.
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.
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)
Ipsilateral Diaphragm function change
Thickening fraction (%) of ipsilateral hemidiaphragm to BPBAC
Measured: day of surgery (1hour before surgery starts and 1hour after surgery ends)
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)
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.
- First posted28 Sep 2018
- Study start15 Oct 2018
- Primary completion5 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Rovira, Hospital General Universitario de Valencia
- Investigators
- Lucas Rovira, PhD, Principal investigator, HGUV
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688724
- Acronym / sponsor ID
- DPOCUS / ROV-DPOCUS-2018-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospital General Universitario de ValenciaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for upper limb surgery
Key inclusion criteria (1 listed)
- Patients scheduled for any type of surgery that requires a supraclavicular or interscalene block.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contralateral Diaphragm function change
Time frame: day of surgery (1 hour before surgery starts and 1 hour after surgery ends)
Thickening fraction (%) change of contralateral hemidiaphragm Before-After Brachial plexus Block
3 secondary outcomes
Ipsilateral Diaphragm function change
Time frame: day of surgery (1hour before surgery starts and 1hour after surgery ends)
Incidence of Postoperative Pulmonary Complications
Time frame: postoperative 30 min after surgery at PACU(post anesthesia care unit)
Incidence of contralateral hemidiaphragm increase after BPBAC.
Time frame: POSTOPERATIVE 30 min after surgery at PACU (post anesthesia care unit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Related trials for Postoperative Pulmonary Complications
Not yet recruiting
Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG)
Postoperative Complications
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Rovira, PhD principal investigator
HGUV
1 site in 1 country: see every site and its status.
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.