AtelectasisNCT02216006
High Fresh Gas Flow After Intubation
A study testing High fresh gas flow, high minute ventilation in people with Atelectasis, run by Region Västmanland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- High fresh gas flow, high minute ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy patients, American Society of Anesthesiology (ASA) I-II
- Patients scheduled for orthopaedic day case surgery in general anaesthesia
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
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
- Being tested
- Control group, conventional ventilatory settings, High fresh gas flow, high minute ventilation
- Keywords
- Atelectasis, Fresh gas flow, Prevention, Oxygenation, Anaesthesia
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group, conventional ventilatory settingsProcedure or surgery
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 ventilationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: High fresh gas flow, high minute ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1-2 hours, just before emergence from anesthesia
Secondary outcomes (1)
Arterial blood gases
Measured: Within 2-3 hours perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erland Ostberg, Region Västmanland
- Investigators
- Mats Enlund, MD, PhD, Study chair, Landstinget i Värmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216006
- Sponsor's protocol ID
- Dnr 2012/335
- Status last verified
- May 2015
- First submitted
- 1 Aug 2014
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02216006
- Acronym / sponsor ID
- Dnr 2012/335
- Conditions
- Atelectasis
- Keywords
- Atelectasis, Fresh gas flow, Prevention, Oxygenation, Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, conventional ventilatory settings | Active comparator | Procedure: Control group, conventional ventilatory settingsHandling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. |
| High fresh gas flow, high minute ventilation | Active comparator | Procedure: High fresh gas flow, high minute ventilationHandling 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy patients, American Society of Anesthesiology (ASA) I-II
- Patients scheduled for orthopaedic day case surgery in general anaesthesia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group, conventional ventilatory settingsHandling 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. | Procedure or surgery | Control group, conventional ventilatory settings |
| High fresh gas flow, high minute ventilationHandling 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. | Procedure or surgery | High fresh gas flow, high minute ventilation |
Primary outcome
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.
1 secondary outcome
Arterial blood gases
Time frame: Within 2-3 hours perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats Enlund, MD, PhD study chair
Landstinget i Värmland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fresh gas flow, high minute ventilation in people with Atelectasis, run by Region Västmanland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atelectasis (time frame: Within 1-2 hours, just before emergence from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.