Oxygenation Test During General Anesthesia

August 31, 2014 updated by: Lennart Edmark, Region Västmanland

Application of Protective Ventilation Improves Oxygenation During and After Anesthesia. Is it Possible That a Special Procedure, an Oxygenation Test, Can Replace Arterial Blood Gases When Evaluating Oxygenation?

The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.

Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.

Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Västerås, Sweden, 721 89
        • Operationskliniken, Västmanlands sjukhus Västerås

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients scheduled for elective surgery of Morbid Obesity.
  • ASA 1-2. (ASA = American Society of Anesthesiologists classification).
  • "Body mass index" (BMI) ≥ 35 but < 50

Exclusion Criteria:

  • "ASA 3"
  • Anticipated difficult intubation.
  • Major bleeding.
  • Problems with ventilation necessitating protocol aberrations.
  • Obstructive sleep apnea syndrome with CPAP treatment at home.
  • Angina Pectoris

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Start O2 100% and CPAP 10, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with an inspiratory oxygen fraction(FIO2) of 1.0, supplied by a continuous positive airway pressure of 10 centimeters of water(cmH2O), during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled CPAP and 100% oxygen.
Procedure: CPAP and 100% oxygen
During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cmH2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal carbon dioxide (CO2) level of 5 %. During emergence from anesthesia 100 % oxygen is used.
Other Names:
  • Preventive ventilation
EXPERIMENTAL: Start O2 100% and CPAP 10, end O2 31%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, supplied by a continuous positive airway pressure of 10 cmH2O, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 0.3 is used. The intervention associated with this arm is labeled CPAP and 31% oxygen.
Procedure: CPAP and 31% oxygen
During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cm H2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal CO2 level of 5 %. During emergence from anesthesia 31 % inspiratory oxygen or the inspiratory oxygen level needed to achieve a SpO2 of at least 96 % (if 31 % oxygen is not enough), is used.
Other Names:
  • Preventive ventilation
EXPERIMENTAL: Start O2 100% and CPAP 0, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, without a continuous positive airway pressure, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled No CPAP and 100% oxygen.
Procedure: No CPAP and 100% oxygen
This intervention follows a standard protocol without the use CPAP during induction of anesthesia.
Other Names:
  • Standard protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
Time Frame: Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.
During anesthesia SpO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 does not go lower than 87 % and compared to SpO2 immediately before anesthesia. SpO2 breathing air one hour after anesthesia is compared to SpO2 before anesthesia.
Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gas values for saturation (SaO2)
Time Frame: 5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.
During anesthesia SaO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 (sic! does not go lower than 87 % and compared to SaO2 immediately before anesthesia. SaO2 breathing air one hour after anesthesia is compared to SaO2 before anesthesia.
5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.
Arterial oxygen tension (PaO2)
Time Frame: 5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.
During anesthesia PaO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 (sic) does not go lower than 87 % and compared to PaO2 immediately before anesthesia. PaO2 breathing air one hour after anesthesia is compared to PaO2 before anesthesia.
5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Västmanland

Investigators

  • Principal Investigator: Göran Hedenstierna, Prof., Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 31, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2011 / 462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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