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Trial registered on ANZCTR


Registration number
ACTRN12617001179325
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
11/08/2017
Date last updated
14/05/2019
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sonographic Monitoring of Diaphragm after Cardiac Surgery
Scientific title
Ultrasonographic Evaluation of the Diaphragm in patients undergoing cardiac surgery.
Secondary ID [1] 292530 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diaphragm dysfunction 304183 0
Condition category
Condition code
Respiratory 303510 303510 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The enrolled patients will undergo to a sonographic measurement of diaphragmatic motion (right and left hemidiaphragmatic excursion) and diaphragmatic thickness (on the right side) the day before surgery, during the weaning trial, the day after the weaning trials and at the patient discharge.
All patients will be evaluated in a semi-recumbent position, with the head of the bed elevated at an angle between 30° and 45°. Ultrasound will be performed using a SonoSite ultrasound system equipped with a 5 MHz convex probe for the subcostal approach and a 13 MHz linear probe for the approach in the zone of apposition.
To evaluate diaphragmatic displacement, the probe is places immediately below the right or left costal margin, between the mid-clavicular and anterior axillary lines, using liver or spleen as acoustic windows. The probe is directed medially, cephalad and dorsally, so that the ultrasound beam reaches perpendicularly the posterior third of the corresponding hemi-diaphragm.
Diaphragm is identified as a hyperechoic line, produced by the pleura tighten adherent to the muscle.The two dimensional (2D) mode is initially used to obtain the best approach and select the exploration line. The M-mode is then used to display the motion of the anatomical structures along the selected line.
To evaluate diaphragmatic thickness,, the probe is placed in the zone of apposition of the diaphragm to the rib cage, between the 8th and the 10th intercostals space in the mid-axillary line, 0,5-2 cm below the costophrenic sinus.
In this area, the diaphragm is observed as a structure made of three distinct layers: the nearest line is the parietal pleura, the deeper one is the peritoneum; the diaphragm is the less echogenic structure between these two lines. The Thickening Fraction (TF) can be calculated as widely described in the literature.
Intervention code [1] 298722 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302887 0
To evaluate if cardiac surgery can reduce the respiratory effort as assessed through the diaphragm ultrasonogaphy
Timepoint [1] 302887 0
The enrolled patients will undergo to a sonographic measurement of diaphragmatic motion to assess the diaphragm thickening fractio (TF) the day before surgery, during the weaning trial daily before extubation, and the day after the weaning trials and at the patient discharge.
Primary outcome [2] 302984 0
To evaluate if cardiac surgery can reduce the respiratory drive as assessed through the diaphragm ultrasonogaphy
Timepoint [2] 302984 0
The enrolled patients will undergo to a sonographic measurement of diaphragmatic motion to assess the diaphragm craniocaudal displacement the day before surgery, during the weaning trial daily before extubation, and the day after the weaning trials and at the patient discharge.
Secondary outcome [1] 337334 0
To evaluate the diaphragmatic dysfunction evolution until the patient discharge
Timepoint [1] 337334 0
Ultrasound diaphragm assessment (i.e. diaphragm displacement and thickening fraction) will be done the day before surgery, during the weaning trial, the day after the weaning trial daily before extubation and at the patient discharge
Secondary outcome [2] 337336 0
To assess the rate of severe diaphragmatic dysfunction, measured like a diaphragmatic excursion trough diaphragmatic ultrasound less than 10mm during normal spontaneous breathing
Timepoint [2] 337336 0
After extubation

Eligibility
Key inclusion criteria
Adult patients that are undergoing an elective heart surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: 1) age <18 years; 2) urgent surgery; 3) death of the patient; 4) elevated hemidiaphragm on a preoperative chest radiographs; 5) presence or history of thoracostomy, pneumothorax, pneumomediastinum, phrenic nerve injury, neuromuscular disease, brain injury

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We therefore have computed our sample size basing on data by Matamis et al (4). A minimum of 63 patients will be required to show a 10% reduction in diaphragm displacement after 24 hours from the surgery, respect to baseline (alpha error = 0.05, desired power 0.80).To evaluate the variation among intra and inter observers measurements, we will compute the interclass coefficient. The normal distribution will be assessed through the Kolmogorov- Smirnov test. Data will be presented as mean and standard deviation or median and interquartile range, Data will be compared with an analisys of variance for repeated measures and a Bonferroni post-hoc test for pairwise comparisons.
Some variables will be also analyzed in relation to the percentage of reduction of the diaphragm displacement. In particular the following variables will be insert in a multiple linear stepwise regression model: patients-related risk factors (age, obesity, chronic obstructive pulmonary disease , diabetes mellitus type 2, hypo or hyper tyrodism) or surgery related factors (cold cardioplegia, left internal mammary artery isolation, aortic clamp time).
Tested variables will be insert in the model for p values <0.05 and removed if p>0.10.
p values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2017
Actual
9/10/2017
Date of last participant enrolment
Anticipated
1/11/2018
Actual
17/09/2018
Date of last data collection
Anticipated
30/11/2018
Actual
19/09/2018
Sample size
Target
63
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 9093 0
Italy
State/province [1] 9093 0

Funding & Sponsors
Funding source category [1] 297101 0
University
Name [1] 297101 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Country [1] 297101 0
Italy
Primary sponsor type
Individual
Name
Federico Longhini
Address
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country
Italy
Secondary sponsor category [1] 296111 0
None
Name [1] 296111 0
Address [1] 296111 0
Country [1] 296111 0
Other collaborator category [1] 279660 0
Individual
Name [1] 279660 0
Antonio Gemelli
Address [1] 279660 0
SC Anestesia e Rianimazione, ospedale Mater Domini, Viale Europa - Loc. Germaneto 88100, Catanzaro
Country [1] 279660 0
Italy
Other collaborator category [2] 279661 0
Individual
Name [2] 279661 0
Paolo Navalesi
Address [2] 279661 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia, Viale Europa - Loc. Germaneto 88100
Catanzaro
Country [2] 279661 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298277 0
Comitato Etico sezione Centro - Regione Calabria
Ethics committee address [1] 298277 0
A.O.U. Mater Domini in Via Tommaso Campanella, 115 Catanzaro
Ethics committee country [1] 298277 0
Italy
Date submitted for ethics approval [1] 298277 0
01/06/2017
Approval date [1] 298277 0
15/06/2017
Ethics approval number [1] 298277 0
124/2017

Summary
Brief summary
A recent analysis by Deg et al. of data collected on 2084 consecutive patients, who underwent cardiac surgery, found 53 phrenic nerve injuries (2,5%).
This prospective study aims to evaluate if cardiac surgery can change diaphragmatic function. The secondary outcomes are:
1) evaluating the diaphragmatic dysfunction until the patient discharge,
2) identifying risk factors patient-correlate (age, body mass index, CPOD, diabetes, hypothyroidism, hyperthyroidism) or surgery correlate (cold cardioplegia, harvesting of the IMA, time of the aortic cross-clump).
3) Recognize severe diaphragmatic dysfunction, measured like a diaphragmatic excursion less than 10mm during normal spontaneous breathing
The enrolled patients will undergo to a sonographic measurement of diaphragmatic motion (right and left hemidiaphragmatic excursion) and diaphragmatic thickness (on the right side) the day before surgery, during the weaning trial, the day after the weaning trials and at the patient discharge.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 76566 0
Prof Paolo Navalesi
Address 76566 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia, Viale Europa - Loc. Germaneto 88100, Catanzaro,
Country 76566 0
Italy
Phone 76566 0
+393355321910
Fax 76566 0
Email 76566 0
[email protected]
Contact person for public queries
Name 76567 0
Federico Longhini
Address 76567 0
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country 76567 0
Italy
Phone 76567 0
+393475395967
Fax 76567 0
Email 76567 0
[email protected]
Contact person for scientific queries
Name 76568 0
Federico Longhini
Address 76568 0
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country 76568 0
Italy
Phone 76568 0
+393475395967
Fax 76568 0
Email 76568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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