Oxygenation Test During General Anesthesia

NCT ID: NCT01559402

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CPAP and 100% oxygen

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

CPAP and 31% oxygen

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

No CPAP and 100% oxygen

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

No CPAP and 100% oxygen

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

Intervention Type: PROCEDURE

Other Intervention Names

Preventive ventilation; Preventive ventilation; Standard protocol.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västmanland

OTHER

Sponsor Role: lead

Responsible Party

Lennart Edmark

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Göran Hedenstierna, Prof.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

Operationskliniken, Västmanlands sjukhus Västerås

Västerås, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2011 / 462

Identifier Type: -

Identifier Source: org_study_id