Clinical trial NCT02980770: Postoperative Complications in Patients With Obesity Hypoventilation Syndrome
Official title: Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Obesity Hypoventilation Syndrome
Hypercapnia
Post-Op Complication
Acid-Base Imbalance
Keywords: Obstructive Sleep Apnea
Obesity Hypoventilation Syndrome
Hypercapnia
Post-Op Complication
Acid-Base Imbalance
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Elazig Education and Research Hospital
name: Mustafa Kemal University
name: Aydin Adnan Menderes University
name: TC Erciyes University
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Haydarpasa Numune Training and Research Hospital
name: Fatih Sultan Mehmet Training and Research Hospital
name: Konya Meram State Hospital
name: Ankara City Hospital Bilkent
name: Adana Numune Training and Research Hospital
name: Tepecik Training and Research Hospital
name: Sakarya University
name: Ankara University
name: Kahramanmaras Sutcu Imam University
name: Trakya University
name: Karadeniz Technical University
name: Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Ufuk University
name: Kasımpasa Training and Research Hospital
name: Nevsehir Public Hospital
name: Hitit University
name: Bulent Ecevit University
name: Medipol University
First posted: 2016-12-02
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive obese patients undergoing elective abdominal surgery

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.

Eligibility 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

Primary outcomes:
measure: Postoperative complications
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
affiliation: Marmara University Medical School
name: Ismail Cinel, Prof Dr
role: STUDY_CHAIR
References: