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NCT Number: NCT01559402

Oxygenation Test During General Anesthesia

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Operationskliniken, Västmanlands sjukhus Västerås

Västerås, 721 89, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP and 100% oxygen

Procedure

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

CPAP and 31% oxygen

Procedure

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

No CPAP and 100% oxygen

Procedure

This intervention follows a standard protocol without the use CPAP during induction of anesthesia.

Other names: Standard protocol.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

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?

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2012
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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