Oxygenation Test During General Anesthesia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

CPAP and 100% oxygen

CPAP and 31% oxygen

No CPAP and 100% oxygen

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Operationskliniken, Västmanlands sjukhus Västerås

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Start O2 100% and CPAP 10, end O2 100%.

Start O2 100% and CPAP 10, end O2 31%.

Start O2 100% and CPAP 0, end O2 100%.

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.

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 Outcome Measures

Arterial blood gas values for saturation (SaO2)

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.

Arterial oxygen tension (PaO2)

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.

Full Information

NCT ID

NCT01559402

First Posted

March 12, 2012

Last Updated

August 31, 2014

Sponsor

Region Västmanland

1. Study Identification

Unique Protocol Identification Number

NCT01559402

Brief Title

Oxygenation Test During General Anesthesia

Official 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?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Västmanland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Start O2 100% and CPAP 10, end O2 100%.

Arm Type

Experimental

Arm Description

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.

Arm Title

Start O2 100% and CPAP 10, end O2 31%.

Arm Type

Experimental

Arm Description

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.

Arm Title

Start O2 100% and CPAP 0, end O2 100%.

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

CPAP and 100% oxygen

Other Intervention Name(s)

Preventive ventilation

Intervention Description

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

Intervention Name(s)

CPAP and 31% oxygen

Other Intervention Name(s)

Preventive ventilation

Intervention Description

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

Intervention Name(s)

No CPAP and 100% oxygen

Other Intervention Name(s)

Standard protocol.

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.

Description

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.

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.

Secondary Outcome Measure Information:

Title

Arterial blood gas values for saturation (SaO2)

Description

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.

Time Frame

5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.

Title

Arterial oxygen tension (PaO2)

Description

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.

Time Frame

5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Göran Hedenstierna, Prof.

Organizational Affiliation

Uppsala University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Operationskliniken, Västmanlands sjukhus Västerås

City

Västerås

ZIP/Postal Code

721 89

Country

Sweden

Morbid Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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