Postoperative Complications in Patients With Obesity Hypoventilation Syndrome (OHBE)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 999

Contacts and Locations

• Study Contact: Name: Ismail Cinel, Prof Dr; Phone Number: +905324129596; Email: cinelismail@yahoo.com
• Study Contact Backup: Name: Yuksel Peker, Prof Dr; Phone Number: +905443484866; Email: yukselpeker26@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Marmara University Pendik Training and Research Hospital
    • Contact: Ismail Cinel, Prof Dr; Phone Number: +905324129596; Email: cinelismail@yahoo.com
    • Contact: Fethi Gül, MD; Phone Number: +905056000385; Email: gulfethi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive obese patients undergoing elective abdominal surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Obstructive Sleep Apnea (OSA); Patients with OSA
Obesity-Hypoventilation Syndrome (OHS); Patients with OHS
Normal Blood Gases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative complications	72 hours

Collaborators and Investigators

• Sponsor: Marmara University
• Collaborators: Bulent Ecevit University; Mustafa Kemal University; TC Erciyes University; Kahramanmaras Sutcu Imam University; Sisli Hamidiye Etfal Training and Research Hospital; Ankara City Hospital Bilkent; Fatih Sultan Mehmet Training and Research Hospital; Medipol University; Tepecik Training and Research Hospital; Nevsehir Public Hospital; Ankara University; Trakya University; Hitit University; Aydin Adnan Menderes University; Karadeniz Technical University; Sakarya University; Konya Meram State Hospital; Ufuk University; Turkiye Yuksek Ihtisas Education and Research Hospital; Haydarpasa Numune Training and Research Hospital; Adana Numune Training and Research Hospital; Dr. Lutfi Kirdar Kartal Training and Research Hospital; Elazig Education and Research Hospital; Kasımpasa Training and Research Hospital
• Investigators: Study Chair: Ismail Cinel, Prof Dr, Marmara University Medical School

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Hypercapnia; Obesity Hypoventilation Syndrome; Acid-Base Imbalance; Post-Op Complication
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Obesity; Postoperative Complications; Hypoventilation; Obesity Hypoventilation Syndrome; Hypercapnia; Acid-Base Imbalance
• Other Study ID Numbers: 70737436-050.06.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO