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Postoperative Complications in Patients With Obesity Hypoventilation Syndrome (OHBE)

M

Marmara University

Status

Unknown

Conditions

Acid-Base Imbalance
Post-Op Complication
Hypercapnia
Obstructive Sleep Apnea
Obesity Hypoventilation Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT02980770
70737436-050.06.04

Details and patient eligibility

About

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.

Full 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.

Enrollment

999 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

999 participants in 3 patient groups

Obstructive Sleep Apnea (OSA)
Description:
Patients with OSA
Obesity-Hypoventilation Syndrome (OHS)
Description:
Patients with OHS
Normal Blood Gases
Description:
Normal Blood Gases

Trial contacts and locations

1

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Central trial contact

Yuksel Peker, Prof Dr; Ismail Cinel, Prof Dr

Data sourced from clinicaltrials.gov

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