Comparison of Two Mechanical Ventilation Modes on Oxygenisation

Comparison of Two Mechanical Ventilation Strategies on Tissue Oxygenization of Patients Undergoing Bariatric Surgery

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

Study Overview

• Status: Completed
• Conditions: Hypoxia; Bariatric Surgery Candidate; Mechanical Ventilation; Tissue Damage

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population involves the elective bariatric surgery patients who have body mass index between 35 and 50 kg/m2.

Description

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 whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenization	Peroperative Non invazive technique of Superficial Tissue Oxygenization	peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Oxygenization-2	Post operative Non invazive technique of Superficial Tissue Oxygenization	post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour
Arterial blood gas analysis	Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation	Peroperative 0. minute - 30. minute - 60. minute
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
Peripheral oxygen saturation	Peripheral Oxygen Saturation (SpO2)	peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Peripheral oxygen saturation-2	Peripheral Oxygen Saturation (SpO2)	post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peroperative hemodynamic measurements	Heart rate, Mean Arterial Blood Pressure	peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Postoperative hemodynamic measurements	Heart rate, Mean Arterial Blood Pressure	post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Carbondioxide	End tidal Carbondioxide measurement	peroperative 15. minute - 30. minute - 45. minute - 60. minute

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2012
• Primary Completion (Actual): March 30, 2013
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: bariatric surgery, tissue oxygenization, ventilation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 01.02.2013-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No