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Completed

NCT Number: NCT02216006

High Fresh Gas Flow After Intubation

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.

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Key information

Conditions

Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landstinget Västmanland

Köping, Västmanland County, 731 30, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Atelectasis

    Time frame: Within 1-2 hours, just before emergence from anesthesia

    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 outcomes

  1. Arterial blood gases

    Time frame: Within 2-3 hours perioperatively

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

High Fresh Gas Flow After Intubation - A Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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