Postoperative Complications in Patients With Obesity Hypoventilation Syndrome

Obstructive Sleep Apnea Clinical Trial

— OHBE  

Official title:

Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980770
• Other study ID #: 70737436-050.06.04
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: April 4, 2017
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Marmara University
• Contact: Ismail Cinel, Prof Dr
• Phone: +905324129596
• Email: cinelismail[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acid-Base Imbalance
• Hypercapnia
• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Obstructive Sleep Apnea
• Post-Op Complication
• Postoperative Complications
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul

Sponsors (25)

Lead Sponsor

Collaborator

Marmara University

Adana Numune Training and Research Hospital, Adnan Menderes University, Ankara Numune Training and Research Hospital, Ankara University, Bulent Ecevit University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Elazig Education and Research Hospital, Erciyes University, Fatih Sultan Mehmet Training and Research Hospital, Haydarpasa Numune Education and Research Hospital, Hitit University, Kahramanmaras Sutcu Imam University, Karadeniz Technical University, Kasimpasa Training and Research Hospital, Konya Training and Research Hospital, Medipol University, Mustafa Kemal University, Nevsehir Public Hospital, Sakarya University, Sisli Hamidiye Etfal Education and Research Hospital, Tepecik Training and Research Hospital, Trakya University, Turkiye Yuksek Ihtisas Education and Research Hospital, Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications		72 hours