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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02980770
Other study ID # 70737436-050.06.04
Secondary ID
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
Health authority
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

Study Design


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
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