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Clinical Trials/NCT01559402
NCT01559402
Completed
Not Applicable

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?

Region Västmanland1 site in 1 country40 target enrollmentMarch 2012
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Region Västmanland
Enrollment
40
Locations
1
Primary Endpoint
Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lennart Edmark

Principal Investigator

Region Västmanland

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Arterial blood gas values for saturation (SaO2)(5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.)
  • Arterial oxygen tension (PaO2)(5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.)

Study Sites (1)

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