NCT01559402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

March 12, 2012

Last Update Submit

August 31, 2014

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (2)

  • 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 Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

CPAP and 100% oxygenPROCEDURE

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.

Also known as: Preventive ventilation
Start O2 100% and CPAP 10, end O2 100%.
CPAP and 31% oxygenPROCEDURE

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.

Also known as: Preventive ventilation
Start O2 100% and CPAP 10, end O2 31%.
No CPAP and 100% oxygenPROCEDURE

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

Also known as: Standard protocol.
Start O2 100% and CPAP 0, end O2 100%.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operationskliniken, Västmanlands sjukhus Västerås

Västerås, 721 89, Sweden

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

OxygenAIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Göran Hedenstierna, Prof.

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 21, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-08

Locations

SE(1)