Diaphragm DiseaseNCT04828408
Diaphragm Functions in Bariatric Surgeries
An observational study of Diaphragm Disease and Pulmonary Function Test, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obesity is an important public health problem all over the world, and its prevalence is increasing every year. In obesity, significant changes occur in the mechanical properties of the lungs and chest wall due to fat deposits in the mediastinum and abdominal cavities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Disease, Pulmonary Function Test, Ultrasonography
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 2 Sep 2019
- 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: Patients undergoing laparoscopic bariatric surgery
Who may be able to join
- Patients with a body mass index (BMI) ˃35,
- age interval of 18-65,
- ASA score II-III undergoing laparoscopic bariatric surgery
Who cannot join
- Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases,
- phrenic nerve damage or diaphragm paralysis,
- those who have undergone thoracic surgery,
- who could not communicate,
- who did not want to participate in the study,
- who used alcohol,
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- those who needed postoperative intensive care,
- those who had surgical complications during surgery,
- those who were switched to open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16290
About this study
Official title: Evaluation of Diaphragm Functions in Laparoscopic Bariatric Surgeries
Obesity is an important public health problem all over the world, and its prevalence is increasing every year. In obesity, significant changes occur in the mechanical properties of the lungs and chest wall due to fat deposits in the mediastinum and abdominal cavities. Upper abdominal surgical procedures usually cause impairment of respiratory functions by affecting respiratory volume and capacity. The risk of postoperative pulmonary complications increases with the decrease in restrictive capacities, hypoxemia, and increased respiratory work. It may also be due to causes such as diaphragm dysfunction, postoperative pain, and surgical incision.Ultrasonography (USG) is a method accepted for evaluating the normal and pathological conditions of the diaphragm. M-mode is used to evaluate the anatomical and functional disorders of the diaphragm. The diaphragm evaluation is performed with the anterior approach in the supine position and with different respiratory maneuvers (sniffing, deep inspiration, normal inspiration).
The aim of the study was to evaluate the diaphragm function by using USG and spirometry methods in patients who underwent bariatric surgery and to investigate the effect of postoperative pain score on diaphragm function.
Read the detailed description
Approval for this single-center, prospective, observational study was performed after the approval of the local Ethics Committee and informed consent from the patients.
Diaphragm ultrasonography was performed before general anesthesia, after general anesthesia in the recovery room, and at the postoperative 24th hour in normal breathing, deep inspiration, and sniffing position. For USG evaluation, while the patients sit in the supine position at an angle of 45⁰, the 2.5-7.5 Mhz convex probe is placed perpendicular to the intercostal spaces through the liver window on the anterior axillary line; The posterior part of the right hemidiaphragm was evaluated by directing it medially, cephalad and dorsally. Diaphragm movements in M-mode were evaluated after detection of the diaphragm in the B-mode. The inspiratory amplitude of the diaphragm (DIA: distance traveled by the diaphragm between the beginning and end of inspiration, cm) in M-mode, inspiratory velocity (IV= DIA/inspiratory time, cm/sec), and expiratory velocity (EV= DIA/expiratory time, cm/sec) measurements were made. VAS scores of the patients were questioned while performing USG.
Pulmonary function tests (PFT) of patients before surgery and the postoperative first day and FVC, FEV1, PEF, FEF25-75, and FEV1/FVC measurements have been recorded.
- Conditions
- Diaphragm Disease, Pulmonary Function Test, Ultrasonography, Bariatric Surgery, Anesthesia
- Being tested
- Bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Patients with a body mass index (BMI) ˃35, age interval of 18-65, and ASA score II-III undergoing laparoscopic bariatric surgery were included in the study. Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases, phrenic nerve damage or diaphragm paralysis, those who have undergone thoracic surgery, who could not communicate, who did not want to participate in the study, who used alcohol, those who needed postoperative intensive care, those who had surgical complications during surgery, and those who were switched to open surgery were not included in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm function
change from baseline in diaphragm inspiratory amplitude at 24 hours
Measured: time from 10 minutes before anesthesia to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Mar 2019
- Primary completion1 Sep 2019
- Study completion2 Sep 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Karasu, MD, Turkiye Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828408
- Sponsor's protocol ID
- 2019/02-16.derya
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 2 Apr 2021
- 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 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragm Functions in Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT04828408
- Acronym / sponsor ID
- 2019/02-16.derya
- Conditions
- Diaphragm Disease, Pulmonary Function Test, Ultrasonography, Bariatric Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 2 Apr 2021 (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.
Obesity is an important public health problem all over the world, and its prevalence is increasing every year. In obesity, significant changes occur in the mechanical properties of the lungs and chest wall due to fat deposits in the mediastinum and abdominal cavities. Upper abdominal surgical procedures usually cause impairment of respiratory functions by affecting respiratory volume and capacity. The risk of postoperative pulmonary complications increases with the decrease in restrictive capacities, hypoxemia, and increased respiratory work. It may also be due to causes such as diaphragm dysfunction, postoperative pain, and surgical incision.Ultrasonography (USG) is a method accepted for evaluating the normal and pathological conditions of the diaphragm. M-mode is used to evaluate the anatomical and functional disorders of the diaphragm. The diaphragm evaluation is performed with the anterior approach in the supine position and with different respiratory maneuvers (sniffing, deep inspiration, normal inspiration).
The aim of the study was to evaluate the diaphragm function by using USG and spirometry methods in patients who underwent bariatric surgery and to investigate the effect of postoperative pain score on diaphragm function.
Detailed description
Approval for this single-center, prospective, observational study was performed after the approval of the local Ethics Committee and informed consent from the patients.
Diaphragm ultrasonography was performed before general anesthesia, after general anesthesia in the recovery room, and at the postoperative 24th hour in normal breathing, deep inspiration, and sniffing position. For USG evaluation, while the patients sit in the supine position at an angle of 45⁰, the 2.5-7.5 Mhz convex probe is placed perpendicular to the intercostal spaces through the liver window on the anterior axillary line; The posterior part of the right hemidiaphragm was evaluated by directing it medially, cephalad and dorsally. Diaphragm movements in M-mode were evaluated after detection of the diaphragm in the B-mode. The inspiratory amplitude of the diaphragm (DIA: distance traveled by the diaphragm between the beginning and end of inspiration, cm) in M-mode, inspiratory velocity (IV= DIA/inspiratory time, cm/sec), and expiratory velocity (EV= DIA/expiratory time, cm/sec) measurements were made. VAS scores of the patients were questioned while performing USG.
Pulmonary function tests (PFT) of patients before surgery and the postoperative first day and FVC, FEV1, PEF, FEF25-75, and FEV1/FVC measurements have been recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic bariatric surgery
Key inclusion criteria (3 listed)
- Patients with a body mass index (BMI) ˃35,
- age interval of 18-65,
- ASA score II-III undergoing laparoscopic bariatric surgery
Key exclusion criteria (9 listed)
- Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases,
- phrenic nerve damage or diaphragm paralysis,
- those who have undergone thoracic surgery,
- who could not communicate,
- who did not want to participate in the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryPatients with a body mass index (BMI) ˃35, age interval of 18-65, and ASA score II-III undergoing laparoscopic bariatric surgery were included in the study. Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases, phrenic nerve damage or diaphragm paralysis, those who have undergone thoracic surgery, who could not communicate, who did not want to participate in the study, who used alcohol, those who needed postoperative intensive care, those who had surgical complications during surgery, and those who were switched to open surgery were not included in the study. | Procedure or surgery | – |
Primary outcome
diaphragm function
Time frame: time from 10 minutes before anesthesia to 24 hours postoperatively
change from baseline in diaphragm inspiratory amplitude at 24 hours
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 2 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Pulmonary Function Test, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 2 Apr 2021. 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 Turkey (Türkiye). 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?
diaphragm function (time frame: time from 10 minutes before anesthesia to 24 hours postoperatively). 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 2 Apr 2021.