High Fresh Gas Flow After Intubation

NCT ID: NCT02216006

Last Updated: 2015-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group, conventional ventilatory settings

Handling of the airway during induction and intubation is performed in a conventional manner.

Initial ventilatory settings are also done in a conventional manner.

Group Type ACTIVE_COMPARATOR

Control group, conventional ventilatory settings

Intervention Type PROCEDURE

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.

High fresh gas flow, high minute ventilation

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.

Group Type ACTIVE_COMPARATOR

High fresh gas flow, high minute ventilation

Intervention Type PROCEDURE

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.

Interventions

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Control group, conventional ventilatory settings

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

High fresh gas flow, high minute ventilation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Västmanland

OTHER

Sponsor Role lead

Responsible Party

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Erland Ostberg

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mats Enlund, MD, PhD

Role: STUDY_CHAIR

Landstinget i Värmland

Locations

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Landstinget Västmanland

Köping, Västmanland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 2012/335

Identifier Type: -

Identifier Source: org_study_id

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