Obstructive Sleep ApneaOHBENCT02980770
Postoperative Complications in Patients With Obesity Hypoventilation Syndrome
An observational study of Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome, Hypercapnia
- How many people
- 999 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive obese patients undergoing elective abdominal surgery
Who may be able to join
- Patients undergoing elective abdominal surgery
- Body-Mass-Index >=30 kg/m2
- Ability to read and speak
- Signed informed consent.
Who cannot join
- Use of diuretics
- Use of theophylline
- Use of respiratory depressing drugs
- Severe lung disease (FEV1/FVC<%50)
- Severe hearth failure (EF<%35)
- Central nervous system or muscle disease
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- Untreated hypothyroidism
- Renal failure (GFR<50)
- Total parenteral nutrition more than 72 hours
- Hypokalemia
- Hyponatremia
- Hypomagnesemia
- Hypoalbuminemia
- Known sleep apnea or obesity hypoventilation syndrome
- Blood transfusion from blood bank within 72 hours prior to surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
Ismail Cinel, Prof Dr, +905324129596, cinelismail@yahoo.com
Fethi Gül, MD, +905056000385, gulfethi@gmail.com
About this study
Official title: Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery and further address its impact on perioperative and postoperative complications.
Read the detailed description
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases. Perioperative and 72-h postoperative complications will be documented.
- Conditions
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome, Hypercapnia, Post-Op Complication, Acid-Base Imbalance
- Keywords
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome, Hypercapnia, Post-Op Complication, Acid-Base Imbalance
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome, Hypercapnia, Postoperative Complications, Acid-Base Imbalance
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 |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | Patients with OSA | |
| Obesity-Hypoventilation Syndrome (OHS) | Patients with OHS | |
| Normal Blood Gases | Normal Blood Gases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Elazig Education and Research Hospital, Mustafa Kemal University, Aydin Adnan Menderes University, TC Erciyes University, Sisli Hamidiye Etfal Training and Research Hospital, Haydarpasa Numune Training and Research Hospital, Fatih Sultan Mehmet Training and Research Hospital, Konya Meram State Hospital, Ankara City Hospital Bilkent, Adana Numune Training and Research Hospital, Tepecik Training and Research Hospital, Sakarya University, Ankara University, Kahramanmaras Sutcu Imam University, Trakya University, Karadeniz Technical University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Turkiye Yuksek Ihtisas Education and Research Hospital, Ufuk University, Kasımpasa Training and Research Hospital, Nevsehir Public Hospital, Hitit University, Bulent Ecevit University, Medipol University
- Responsible party
- Sponsor
- Investigators
- Ismail Cinel, Prof Dr, Study chair, Marmara University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980770
- Sponsor's protocol ID
- 70737436-050.06.04
- Acronym
- OHBE
- Status last verified
- Apr 2017
- First submitted
- 30 Nov 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02980770
- Acronym / sponsor ID
- OHBE / 70737436-050.06.04
- Conditions
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome, Hypercapnia, Post-Op Complication, Acid-Base Imbalance
- Keywords
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome, Hypercapnia, Post-Op Complication, Acid-Base Imbalance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Elazig Education and Research Hospital, Mustafa Kemal University, Aydin Adnan Menderes University, TC Erciyes University, Sisli Hamidiye Etfal Training and Research Hospital, Haydarpasa Numune Training and Research Hospital, Fatih Sultan Mehmet Training and Research Hospital, Konya Meram State Hospital, Ankara City Hospital Bilkent, Adana Numune Training and Research Hospital, Tepecik Training and Research Hospital, Sakarya University, Ankara University, Kahramanmaras Sutcu Imam University, Trakya University, Karadeniz Technical University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Turkiye Yuksek Ihtisas Education and Research Hospital, Ufuk University, Kasımpasa Training and Research Hospital, Nevsehir Public Hospital, Hitit University, Bulent Ecevit University, Medipol University
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- 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.
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery and further address its impact on perioperative and postoperative complications.
Detailed description
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases. Perioperative and 72-h postoperative complications will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | – | –Patients with OSA |
| Obesity-Hypoventilation Syndrome (OHS) | – | –Patients with OHS |
| Normal Blood Gases | – | –Normal Blood Gases |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive obese patients undergoing elective abdominal surgery
Key inclusion criteria (4 listed)
- Patients undergoing elective abdominal surgery
- Body-Mass-Index >=30 kg/m2
- Ability to read and speak
- Signed informed consent.
Key exclusion criteria (15 listed)
- Use of diuretics
- Use of theophylline
- Use of respiratory depressing drugs
- Severe lung disease (FEV1/FVC<%50)
- Severe hearth failure (EF<%35)
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
Postoperative complications
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Ismail Cinel, Prof Dr study chair
Marmara University Medical School
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 Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome, run by Marmara University 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 4 inclusion and 15 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 6 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail Cinel, Prof Dr (+905324129596, cinelismail@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 72 hours). 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 6 Apr 2017.