Diaphragm DiseaseNCT03126838
Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome
An observational study of Diaphragm Disease, run by National Heart Institute, Egypt at 1 site in Egypt.
Trial summary
This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Disease
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 100 adult patients who are ready for elective cardiac surgery.
Who may be able to join
- 18 years old and older
- Planned cardiac surgery
- Ready for weaning from mechanical ventilation (fraction of inspired oxygen (FIO2) ≤ 50%, positive end-expiratory pressure(PEEP) level≤ 5 centimeter water (cmH2O), respiratory rate ≤30 breaths/min, partial pressure of oxygen in arterial blood(PaO2)/FIO2 ratio >200 , Glasgow coma score ≥14).
- Stable cardiovascular status (i.e., heart rate <120 beats/min; systolic blood pressure, 90-160 mmHg; and no or minimal vasopressor use, i.e., dopamine or dobutamine ≤5 μg/kg/min or noradrenaline ≤0.05 μg/kg/min).
- Stable metabolic status (i.e., electrolytes and glycaemia within normal range, body temperature <38 °C, hemoglobinemia ≥8-10 g/dL).
Who cannot join
- Patients with a history of diaphragmatic or neuromuscular disease or evidence of pneumothorax or pneumomediastinum.
- Patients with low EF (EF ≤ 30%).
- Patients with post-operative cerebrovascular stroke.
- Reventilation due to cardiac cause ( arrest, arrhythmias, or failure)
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Heart Institute
Giza, Embaba
Faten Fa El sayed, MD, 00201005586659, Faten-icu@hotmail.com
About this study
Official title: Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome; Prospective Observational Study
This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery.
Read the detailed description
Diaphragmatic dysfunction will be assessed by ultrasonography the day before operation and first post operative day, by measuring diaphragmatic thickening during inspiration and expiration.incidence of diaphragmatic dysfunction and its effect on outcome of surgery then will be analysed.
- Conditions
- Diaphragm Disease
- Keywords
- diaphragm, ultrasound, dysfunction, cardiac surgery, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diaphragmatic dysfunction | diaphragmatic displacement < 10 ml, and / OR diaphragmatic thickening fraction < 36 %. | |
| non diaphragmatic dysfunction | diaphragmatic displacement > 10 ml, and / OR diaphragmatic thickening fraction > 36 %. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion.
diaphragmatic excursion (displacement, cm)
Measured: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
diaphragmatic dysfunction post cardiac surgery.
diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration]
/ Thickness at end expiration
Measured: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
Secondary outcomes (7)
. Diaphragmatic excursion
diaphragmatic excursion (displacement, cm)
Measured: the day before surgery
• Diaphragm dysfunction before surgery
diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration]
/ Thickness at end expiration
Measured: the day before surgery
Left ventricular ejection fraction
as indicator of cardiac function
Measured: the day before surgery
• Total ventilation time
in term of hours (in diaphragmatic dysfunction group)
Measured: from time of addmission to surgical ICU up to 1 week
• Extracorporeal circulation duration
cardiopulmonary bypass time in term of minutes
Measured: peroperative
• Ventilation free days.
after extubation first time tell end of ICU stay, in term of days (in diaphragmatic dysfunction group)
Measured: from time of admission to surgical ICU up to 1 week
• Total ICU stay
in term of days (in diaphragmatic dysfunction group)
Measured: from time of admission to surgical ICU up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Mar 2017
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DiseaseStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ibrahim Shawky Morsy Omara, National Heart Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126838
- Sponsor's protocol ID
- NHIEgypt ,670/2017
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03126838
- Acronym / sponsor ID
- NHIEgypt ,670/2017
- Conditions
- Diaphragm Disease
- Keywords
- diaphragm, ultrasound, dysfunction, cardiac surgery, weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Heart Institute, EgyptOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 24 Apr 2017 (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.
This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery.
Detailed description
Diaphragmatic dysfunction will be assessed by ultrasonography the day before operation and first post operative day, by measuring diaphragmatic thickening during inspiration and expiration.incidence of diaphragmatic dysfunction and its effect on outcome of surgery then will be analysed.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic dysfunction | – | –diaphragmatic displacement < 10 ml, and / OR diaphragmatic thickening fraction < 36 %. |
| non diaphragmatic dysfunction | – | –diaphragmatic displacement > 10 ml, and / OR diaphragmatic thickening fraction > 36 %. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 adult patients who are ready for elective cardiac surgery.
Key inclusion criteria (5 listed)
- 18 years old and older
- Planned cardiac surgery
- Ready for weaning from mechanical ventilation (fraction of inspired oxygen (FIO2) ≤ 50%, positive end-expiratory pressure(PEEP) level≤ 5 centimeter water (cmH2O), respiratory rate ≤30 breaths/min, partial pressure of oxygen in arterial blood(PaO2)/FIO2 ratio >200 , Glasgow coma score ≥14).
- Stable cardiovascular status (i.e., heart rate <120 beats/min; systolic blood pressure, 90-160 mmHg; and no or minimal vasopressor use, i.e., dopamine or dobutamine ≤5 μg/kg/min or noradrenaline ≤0.05 μg/kg/min).
- Stable metabolic status (i.e., electrolytes and glycaemia within normal range, body temperature <38 °C, hemoglobinemia ≥8-10 g/dL).
Key exclusion criteria (5 listed)
- Patients with a history of diaphragmatic or neuromuscular disease or evidence of pneumothorax or pneumomediastinum.
- Patients with low EF (EF ≤ 30%).
- Patients with post-operative cerebrovascular stroke.
- Reventilation due to cardiac cause ( arrest, arrhythmias, or failure)
- Patient refusal.
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
Diaphragmatic excursion.
Time frame: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
diaphragmatic excursion (displacement, cm)
diaphragmatic dysfunction post cardiac surgery.
Time frame: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration] / Thickness at end expiration
7 secondary outcomes
. Diaphragmatic excursion
Time frame: the day before surgery
• Diaphragm dysfunction before surgery
Time frame: the day before surgery
Left ventricular ejection fraction
Time frame: the day before surgery
• Total ventilation time
Time frame: from time of addmission to surgical ICU up to 1 week
• Extracorporeal circulation duration
Time frame: peroperative
• Ventilation free days.
Time frame: from time of admission to surgical ICU up to 1 week
• Total ICU stay
Time frame: from time of admission to surgical ICU up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
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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.
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 Diaphragm Disease, run by National Heart Institute, Egypt at 1 site in Egypt.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic excursion. (time frame: at the beginning of the spontaneous breathing trial (around 4hours after surgery).). The study lists 2 primary outcomes in all. 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 24 Apr 2017.