NCT02980770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

November 30, 2016

Last Update Submit

April 4, 2017

Conditions

Obstructive Sleep ApneaObesity Hypoventilation SyndromeHypercapniaPost-Op ComplicationAcid-Base Imbalance

Keywords

Obstructive Sleep ApneaObesity Hypoventilation SyndromeHypercapniaPost-Op ComplicationAcid-Base Imbalance

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    72 hours

Study Arms (3)

Obstructive Sleep Apnea (OSA)

Patients with OSA

Obesity-Hypoventilation Syndrome (OHS)

Patients with OHS

Normal Blood Gases

Normal Blood Gases

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive obese patients undergoing elective abdominal surgery

You may qualify if:

  • Patients undergoing elective abdominal surgery
  • Body-Mass-Index \>=30 kg/m2
  • Ability to read and speak
  • Signed informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biochemistry, blood gases

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesity Hypoventilation SyndromeHypercapniaPostoperative ComplicationsAcid-Base Imbalance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHypoventilationRespiratory InsufficiencyObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesMetabolic Diseases

Study Officials

  • Ismail Cinel, Prof Dr

    Marmara University Medical School

    STUDY CHAIR

Central Study Contacts

Ismail Cinel, Prof Dr

CONTACT

+905324129596cinelismail@yahoo.com

Yuksel Peker, Prof Dr

CONTACT

+905443484866yukselpeker26@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

April 6, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)