OHBE: Postoperative Complications in Patients With Obesity Hypoventilation Syndrome

• Sponsor: Marmara University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02980770
• Collaborator: Elazig Education and Research Hospital (Other), Mustafa Kemal University (Other), Aydin Adnan Menderes University (Other), TC Erciyes University (Other), Sisli Hamidiye Etfal Training and Research Hospital (Other), Haydarpasa Numune Training and Research Hospital (Other), Fatih Sultan Mehmet Training and Research Hospital (Other), Konya Meram State Hospital (Other), Ankara City Hospital Bilkent (Other), Adana Numune Training and Research Hospital (Other), Tepecik Training and Research Hospital (Other), Sakarya University (Other), Ankara University (Other), Kahramanmaras Sutcu Imam University (Other), Trakya University (Other), Karadeniz Technical University (Other), Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other), Turkiye Yuksek Ihtisas Education and Research Hospital (Other), Ufuk University (Other), Kasımpasa Training and Research Hospital (Other), Nevsehir Public Hospital (Other), Hitit University (Other), Bulent Ecevit University (Other), Medipol University (Other)
• Enrollment: 999
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 52.7

Study Details

Study Description

Brief 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. 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 or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Hypercapnia; Post-Op Complication; Acid-Base Imbalance

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

• Study Type: Observational
• Anticipated Enrollment: 999 participants
• 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
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Obstructive Sleep Apnea (OSA) Patients with OSA
Obesity-Hypoventilation Syndrome (OHS) Patients with OHS
Normal Blood Gases Normal Blood Gases

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Pendik Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Marmara University
• 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

Investigators

• Study Chair: Ismail Cinel, Prof Dr, Marmara University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marmara University
• ClinicalTrials.gov Identifier: NCT02980770
• Other Study ID Numbers: 70737436-050.06.04
• First Posted: Dec 2, 2016
• Last Update Posted: Apr 6, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Acid-Base Imbalance; Syndrome; Postoperative Complications; Hypercapnia

Study Results

No Results Posted as of Apr 6, 2017