High Fresh Gas Flow After Intubation

NCT02216006 | Completed

• 1 other identifier: Dnr 2012/335
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Keywords

Atelectasis; Fresh gas flow; Prevention; Oxygenation; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1-2 hours, just before emergence from anesthesia

Secondary Outcomes (1)

• Arterial blood gases

  Within 2-3 hours perioperatively

Study Arms (2)

Control group, conventional ventilatory settings

ACTIVE COMPARATOR

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

Procedure: Control group, conventional ventilatory settings

High fresh gas flow, high minute ventilation

ACTIVE COMPARATOR

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.

Procedure: High fresh gas flow, high minute ventilation

Interventions

Control group, conventional ventilatory settings 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.

Control group, conventional ventilatory settings

High fresh gas flow, high minute ventilation 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.

High fresh gas flow, high minute ventilation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Landstinget Västmanland

Köping, Västmanland County, 731 30, Sweden

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mats Enlund, MD, PhD

  Landstinget i Värmland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

SE (1)