Postoperative Complications in Patients With Obesity Hypoventilation Syndrome

• Conditions: Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea; Hypercapnia; Acid-Base Imbalance; Post-Op Complication

• Registration Number: NCT02980770
• Lead Sponsor: Marmara University

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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 999

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	72 hours

Trial Locations

Locations (1)

Marmara University Pendik Training and Research Hospital; 🇹🇷 Istanbul, Turkey