AtelectasisNCT02548416
Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
A study testing Positive end-expiratory pressure in people with Atelectasis, run by Region Västmanland at 1 site in Sweden.
Trial summary
Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Positive end-expiratory pressure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2015to Nov 2016
- 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 subjects, American Society of Anesthesiology (ASA) I-II.
- Patients scheduled for non-abdominal day case surgery under general anaesthesia.
Who cannot join
- ASA class III or higher.
- Body Mass Index (BMI) 30 or higher.
- Arterial oxygen saturation (SpO2) <96% breathing air.
- Chronic Obstructive Pulmonary Disease (COPD).
- Ischaemic heart disease.
- Known or anticipated difficult airway.
- Active smokers and ex-smokers with a history of more than 6 pack years.
- Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).
Trial locations and contacts
1 site in 1 country.
About this study
Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.
The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.
- Conditions
- Atelectasis
- Being tested
- Positive end-expiratory pressure, Control group, zero PEEP
- Keywords
- Atelectasis, Positive End-Expiratory Pressure, Oxygenation, Anaesthesia, Computed tomography
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressureProcedure or surgery
Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium.
As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Control group, zero PEEPProcedure or surgery
Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Zero PEEP is used.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| PEEP group | Active comparator | Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure. Receives: Procedure: Positive end-expiratory pressure |
| Control group zero PEEP | Active comparator | Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure. Receives: Procedure: Control group, zero PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of atelectasis expressed as centimeter^2
The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
Measured: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
Measurement of aeras with different aeration in the particular CT scan.
The areas of different aeration are assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
Measured: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
Secondary outcomes (2)
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Arterial blood gas samples will be drawn and analyzed at the same time as the computed tomography scan will be undertaken.
Measured: Within 1-2 hours, just before emergence from anesthesia. At end of surgery but before emergence from anaesthesia, at the same time as the lungs are investigated by computed tomography.
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Arterial blood gas samples will be drawn and analyzed 15 minutes after emergence from anesthesia and extubation.
Measured: Within 2 hours perioperatively, 15 minutes after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
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
- Lennart Edmark, Study director, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548416
- Sponsor's protocol ID
- Dnr 2015/338
- Status last verified
- Nov 2016
- First submitted
- 1 Sep 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
- ClinicalTrials.gov ID
- NCT02548416
- Acronym / sponsor ID
- Dnr 2015/338
- Conditions
- Atelectasis
- Keywords
- Atelectasis, Positive End-Expiratory Pressure, Oxygenation, Anaesthesia, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Sep 2015 (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 anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.
The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP group | Active comparator | Procedure: Positive end-expiratory pressureInduction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure. |
| Control group zero PEEP | Active comparator | Procedure: Control group, zero PEEPInduction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure. |
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 subjects, American Society of Anesthesiology (ASA) I-II.
- Patients scheduled for non-abdominal day case surgery under general anaesthesia.
Key exclusion criteria (8 listed)
- ASA class III or higher.
- Body Mass Index (BMI) 30 or higher.
- Arterial oxygen saturation (SpO2) <96% breathing air.
- Chronic Obstructive Pulmonary Disease (COPD).
- Ischaemic 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 |
|---|---|---|
| Positive end-expiratory pressureInduction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. | Procedure or surgery | PEEP group |
| Control group, zero PEEPInduction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Zero PEEP is used. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. | Procedure or surgery | Control group zero PEEP |
Primary outcome
Area of atelectasis expressed as centimeter^2
Time frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
Measurement of aeras with different aeration in the particular CT scan.
Time frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
The areas of different aeration are assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
2 secondary outcomes
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Time frame: Within 1-2 hours, just before emergence from anesthesia. At end of surgery but before emergence from anaesthesia, at the same time as the lungs are investigated by computed tomography.
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Time frame: Within 2 hours perioperatively, 15 minutes after extubation.
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 21 Nov 2017.
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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.
Lennart Edmark study director
Region Västmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive end-expiratory pressure 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 8 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 21 Nov 2017. 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?
Area of atelectasis expressed as centimeter^2 (time frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.). The study lists 2 primary outcomes in all. 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 21 Nov 2017.