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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04389047
Other study ID # 01.02.2013-228
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2012
Est. completion date March 30, 2018

Study information

Verified date May 2020
Source Bagcilar Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.


Description:

Aim of the study is to evaluate and compare the effects of two different mechanical ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who scheduled for bariatric surgery.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 30, 2018
Est. primary completion date March 30, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery

Exclusion Criteria:

Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whio has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bagcilar Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygenization Peroperative Non invazive technique of Superficial Tissue Oxygenization peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Primary Oxygenization-2 Post operative Non invazive technique of Superficial Tissue Oxygenization post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour
Primary Arterial blood gas analysis Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation Peroperative 0. minute - 30. minute - 60. minute
Primary Arterial blood gas analysis-2 Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Primary Peripheral oxygen saturation Peripheral Oxygen Saturation (SpO2) peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Primary Peripheral oxygen saturation-2 Peripheral Oxygen Saturation (SpO2) post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Secondary Peroperative hemodynamic measurements Heart rate, Mean Arterial Blood Pressure peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Secondary Postoperative hemodynamic measurements Heart rate, Mean Arterial Blood Pressure post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Secondary Carbondioxide End tidal Carbondioxide measurement peroperative 15. minute - 30. minute - 45. minute - 60. minute
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