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High Fresh Gas Flow After Intubation

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Control group, conventional ventilatory settings
High fresh gas flow, high minute ventilation
Sponsored by
Region Västmanland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring Atelectasis, Fresh gas flow, Prevention, Oxygenation, Anaesthesia

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy patients, American Society of Anesthesiology (ASA) I-II
  • Patients scheduled for orthopaedic day case surgery in general anaesthesia

Exclusion Criteria:

  • ASA class III or higher
  • Body Mass Index (BMI) 30 or higher
  • Arterial oxygen saturation (SpO2) <94% breathing air
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Ischemic heart disease
  • Haemoglobin <100g/L
  • Known or anticipated difficult airway and/or intubation
  • Active smokers and ex-smokers with a history of more than 6 pack years
  • Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis

Sites / Locations

  • Landstinget Västmanland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group, conventional ventilatory settings

High fresh gas flow, high minute ventilation

Arm Description

Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner.

Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.

Outcomes

Primary Outcome Measures

Atelectasis
The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.

Secondary Outcome Measures

Arterial blood gases

Full Information

First Posted
August 1, 2014
Last Updated
May 12, 2015
Sponsor
Region Västmanland
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1. Study Identification

Unique Protocol Identification Number
NCT02216006
Brief Title
High Fresh Gas Flow After Intubation
Official Title
High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Västmanland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Atelectasis is common during and after general anesthesia. Atelectasis develops early if preoxygenation with 100% oxygen is used and continuously used during induction until endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation maneuver immediately after confirming a successful intubation, reduces the area of atelectasis as investigated by computed tomography compared to a standard procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
Atelectasis, Fresh gas flow, Prevention, Oxygenation, Anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group, conventional ventilatory settings
Arm Type
Active Comparator
Arm Description
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner.
Arm Title
High fresh gas flow, high minute ventilation
Arm Type
Active Comparator
Arm Description
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.
Intervention Type
Procedure
Intervention Name(s)
Control group, conventional ventilatory settings
Intervention Description
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Intervention Type
Procedure
Intervention Name(s)
High fresh gas flow, high minute ventilation
Intervention Description
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Primary Outcome Measure Information:
Title
Atelectasis
Description
The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.
Time Frame
Within 1-2 hours, just before emergence from anesthesia
Secondary Outcome Measure Information:
Title
Arterial blood gases
Time Frame
Within 2-3 hours perioperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy patients, American Society of Anesthesiology (ASA) I-II Patients scheduled for orthopaedic day case surgery in general anaesthesia Exclusion Criteria: ASA class III or higher Body Mass Index (BMI) 30 or higher Arterial oxygen saturation (SpO2) <94% breathing air Chronic Obstructive Pulmonary Disease (COPD) Ischemic heart disease Haemoglobin <100g/L Known or anticipated difficult airway and/or intubation Active smokers and ex-smokers with a history of more than 6 pack years Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Enlund, MD, PhD
Organizational Affiliation
Landstinget i Värmland
Official's Role
Study Chair
Facility Information:
Facility Name
Landstinget Västmanland
City
Köping
State/Province
Västmanland
ZIP/Postal Code
731 30
Country
Sweden

12. IPD Sharing Statement

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High Fresh Gas Flow After Intubation

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