Postoperative Complications in Patients With Obesity Hypoventilation Syndrome

NCT ID: NCT02980770

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obstructive Sleep Apnea (OSA)

Patients with OSA

No interventions assigned to this group

Obesity-Hypoventilation Syndrome (OHS)

Patients with OHS

No interventions assigned to this group

Normal Blood Gases

Normal Blood Gases

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elazig Education and Research Hospital

UNKNOWN

Sponsor Role collaborator

Mustafa Kemal University

OTHER

Sponsor Role collaborator

Aydin Adnan Menderes University

OTHER

Sponsor Role collaborator

TC Erciyes University

OTHER

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role collaborator

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role collaborator

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role collaborator

Konya Meram State Hospital

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role collaborator

Adana Numune Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Tepecik Training and Research Hospital

OTHER

Sponsor Role collaborator

Sakarya University

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role collaborator

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role collaborator

Trakya University

OTHER

Sponsor Role collaborator

Karadeniz Technical University

OTHER

Sponsor Role collaborator

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Turkiye Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ufuk University

OTHER

Sponsor Role collaborator

Kasımpasa Training and Research Hospital

UNKNOWN

Sponsor Role collaborator

Nevsehir Public Hospital

OTHER_GOV

Sponsor Role collaborator

Hitit University

OTHER

Sponsor Role collaborator

Bulent Ecevit University

OTHER

Sponsor Role collaborator

Medipol University

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ismail Cinel, Prof Dr

Role: STUDY_CHAIR

Marmara University Medical School

Locations

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Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ismail Cinel, Prof Dr

Role: CONTACT

+905324129596

Yuksel Peker, Prof Dr

Role: CONTACT

+905443484866

Facility Contacts

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Ismail Cinel, Prof Dr

Role: primary

+905324129596

Fethi Gül, MD

Role: backup

+905056000385

Other Identifiers

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70737436-050.06.04

Identifier Type: -

Identifier Source: org_study_id

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