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Postoperative Complications in Patients With Obesity Hypoventilation Syndrome (OHBE)

This study is currently recruiting participants.
Verified April 2017 by Marmara University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980770
First Posted: December 2, 2016
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Elazig Education and Research Hospital
Mustafa Kemal University
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 Training and Research Hospital
Ankara Numune Training and Research Hospital
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
Information provided by (Responsible Party):
Marmara University
  Purpose
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.

Condition
Obstructive Sleep Apnea Obesity Hypoventilation Syndrome Hypercapnia Post-Op Complication Acid-Base Imbalance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by Marmara University:

Primary Outcome Measures:
  • Postoperative complications [ Time Frame: 72 hours ]

Biospecimen Retention:   Samples Without DNA
Biochemistry, blood gases

Estimated Enrollment: 999
Study Start Date: November 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obstructive Sleep Apnea (OSA)
Patients with OSA
Obesity-Hypoventilation Syndrome (OHS)
Patients with OHS
Normal Blood Gases
Normal Blood Gases

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive obese patients undergoing elective abdominal surgery
Criteria

Inclusion Criteria:

  • Patients undergoing elective abdominal surgery
  • Body-Mass-Index >=30 kg/m2
  • Ability to read and speak
  • Signed informed consent.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980770


Contacts
Contact: Ismail Cinel, Prof Dr +905324129596 cinelismail@yahoo.com
Contact: Yuksel Peker, Prof Dr +905443484866 yukselpeker26@gmail.com

Locations
Turkey
Marmara University Pendik Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Ismail Cinel, Prof Dr    +905324129596    cinelismail@yahoo.com   
Contact: Fethi Gül, MD    +905056000385    gulfethi@gmail.com   
Sponsors and Collaborators
Marmara University
Elazig Education and Research Hospital
Mustafa Kemal University
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 Training and Research Hospital
Ankara Numune Training and Research Hospital
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
Investigators
Study Chair: Ismail Cinel, Prof Dr Marmara University Medical School
  More Information

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02980770     History of Changes
Other Study ID Numbers: 70737436-050.06.04
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marmara University:
Obstructive Sleep Apnea
Obesity Hypoventilation Syndrome
Hypercapnia
Post-Op Complication
Acid-Base Imbalance

Additional relevant MeSH terms:
Syndrome
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Postoperative Complications
Hypoventilation
Hypercapnia
Obesity Hypoventilation Syndrome
Acid-Base Imbalance
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Metabolic Diseases