Air InsufflationNCT02238691
Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction, With or Without PEEP
A study testing Mask ventilation with PEEP via a face mask device in people with Air Insufflation and Regurgitation, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Insufflation, Regurgitation
- What is being tested?
- Mask ventilation with PEEP via a face mask device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Sep 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female age 18-40 years
- Signed and informed consent
- Subject will and is assumed to be able to follow protocol
Who cannot join
- Known gastro intestinal/heart/lung/kidney or neurological disease
- Use of drugs that interfere with esophageal motility
- Diabetes
- Pregnancy or breastfeeding
- BMI >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction
Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The investigators aim to compare the risk of gastric insufflation regarding mask ventilation technique, with or without positive end expiratory pressure. For measurements a High Resolution Impedance Manometry Catheter is used.
Read the detailed description
Anesthetic induction agents cause a number of physiological changes within the respiratory system. Almost every induction agent causes apnoea. There is a reduction of FRC and an increase in airway resistance. Combined with preoxygenation with a high fraction of oxygen there is a significant risk of pulmonary atelectasis. Adding a continuous positive pressure during ventilation of the apnoeic patient improves many of the respiratory effects caused by induction agents. However the added continuous pressure will increase the total inspiratory pressure and a high inspiratory pressure is associated with an increased risk of gastric insufflation during mask ventilation. On the other hand there are data suggesting that continuous positive pressure is beneficial in treatment of GERD-symptoms.
The investigators hypothesis is, if performed correctly, that the continuous positive pressure will not increase the risk of gastric insufflation. In order to investigate this matter 30 healthy human subjects will undergo anesthetic induction, 15 with no PEEP added and 15 with a PEEP of 10 cm H2O during mask ventilation.
Protocol:
- Preoxygenation, 100 % oxygen via Face mask for 3 minutes with 0 PEEP or 10 cm H2O PEEP.
- Start of Remifentanil Target Controlled Infusion, target concentration 6 ng/ml.
- Propofol 2-2.5mg/kg to adequate depth of anesthesia.
- 30 seconds after apnea mask ventilation with Dräger ZEUS IE starting with an inspiratory pressure of 3cm H2O that is gradually increased to a maximum of 30 cm H20 or to signs of air insufflation in the esophagus. Group 1 with 0 PEEP and group 2 with 10 cm H2O PEEP.
- End of Remifentanil- and Propofol infusion.
Pressures and passage of air or liquid from pharynx to stomach will be continuously registered during the procedure. For measurements a High Resolution Impedance Manometry Catheter with the ability to measure pressures and impedance simultaneously will be used.
The esophagus and the stomach is divided into four functional units for analysis.
- The upper esophageal sphincter
- The esophageal body (3 cm below upper esophageal sphincter to 3 cm over the lower esophageal sphincter)
- The lower esophageal sphincter
- The stomach (3 cm below the lower esophageal sphincter)
The different units are detected in pressure plots where the levels of pressure reflects the anatomical units. Manometric values is specified in mmHg. For detection of passage of air and flow of liquid an impedance baseline is set before measurements start. Passage of air is defined as a sudden rise in impedance of 1 kΩ in anterograde direction. Detection of fluid is defined as a 50% decline in impedance. For analysis of data Mano View analysis software is used.
Pressures and impedance will be continuously recorded during the time frame from preoxygenation to maximum inspiratory pressures are reached. Data will be analysed at each level of pressure 3, 5, 10, 15, 20, 25 and 30 cm H2O. Contained data will be statistically compared between groups.
- Conditions
- Air Insufflation, Regurgitation
- Being tested
- Mask ventilation with PEEP via a face mask device
- Keywords
- PEEP, Air insufflation, Mask ventilation, Esophageal manometry, Esophageal impedance
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask ventilation with PEEP via a face mask deviceProcedure or surgery
15 subjects will undergo anesthetic induction with an application of PEEP of 10 cm H2O during mask ventilation via a face mask.
15 subjects will undergo anesthetic induction without PEEP during mask ventilation via a face mask.
| Study group | Role | What they receive |
|---|---|---|
| Mask ventilation with PEEP | Experimental | 15 subjects will undergo anesthetic induction with application of PEEP of 10 cm H2O during mask ventilation. Receives: Procedure: Mask ventilation with PEEP via a face mask device |
| Mask ventilation without PEEP | No intervention | 15 subjects will undergo anesthetic induction without PEEP during mask ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of inspiratory pressure for gastric insufflation
Measured: One hour
Secondary outcomes (1)
Pressure changes in the esophagus related to ventilation technique.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Air InsufflationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex de Leon, Örebro University, Sweden
- Investigators
- Alex deLeon, MD, Phd, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238691
- Sponsor's protocol ID
- Pelles PEEP-studie
- Status last verified
- Apr 2016
- First submitted
- 13 Aug 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cajander P, Edmark L, Ahlstrand R, Magnuson A, de Leon A. Effect of positive end-expiratory pressure on gastric insufflation during induction of anaesthesia when using pressure-controlled ventilation via a face mask: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):625-632. doi: 10.1097/EJA.0000000000001016.
PubMed 31116114
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction
- ClinicalTrials.gov ID
- NCT02238691
- Acronym / sponsor ID
- Pelles PEEP-studie
- Conditions
- Air Insufflation, Regurgitation
- Keywords
- PEEP, Air insufflation, Mask ventilation, Esophageal manometry, Esophageal impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Sep 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.
Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The investigators aim to compare the risk of gastric insufflation regarding mask ventilation technique, with or without positive end expiratory pressure. For measurements a High Resolution Impedance Manometry Catheter is used.
Detailed description
Anesthetic induction agents cause a number of physiological changes within the respiratory system. Almost every induction agent causes apnoea. There is a reduction of FRC and an increase in airway resistance. Combined with preoxygenation with a high fraction of oxygen there is a significant risk of pulmonary atelectasis. Adding a continuous positive pressure during ventilation of the apnoeic patient improves many of the respiratory effects caused by induction agents. However the added continuous pressure will increase the total inspiratory pressure and a high inspiratory pressure is associated with an increased risk of gastric insufflation during mask ventilation. On the other hand there are data suggesting that continuous positive pressure is beneficial in treatment of GERD-symptoms.
The investigators hypothesis is, if performed correctly, that the continuous positive pressure will not increase the risk of gastric insufflation. In order to investigate this matter 30 healthy human subjects will undergo anesthetic induction, 15 with no PEEP added and 15 with a PEEP of 10 cm H2O during mask ventilation.
Protocol:
- Preoxygenation, 100 % oxygen via Face mask for 3 minutes with 0 PEEP or 10 cm H2O PEEP.
- Start of Remifentanil Target Controlled Infusion, target concentration 6 ng/ml.
- Propofol 2-2.5mg/kg to adequate depth of anesthesia.
- 30 seconds after apnea mask ventilation with Dräger ZEUS IE starting with an inspiratory pressure of 3cm H2O that is gradually increased to a maximum of 30 cm H20 or to signs of air insufflation in the esophagus. Group 1 with 0 PEEP and group 2 with 10 cm H2O PEEP.
- End of Remifentanil- and Propofol infusion.
Pressures and passage of air or liquid from pharynx to stomach will be continuously registered during the procedure. For measurements a High Resolution Impedance Manometry Catheter with the ability to measure pressures and impedance simultaneously will be used.
The esophagus and the stomach is divided into four functional units for analysis.
- The upper esophageal sphincter
- The esophageal body (3 cm below upper esophageal sphincter to 3 cm over the lower esophageal sphincter)
- The lower esophageal sphincter
- The stomach (3 cm below the lower esophageal sphincter)
The different units are detected in pressure plots where the levels of pressure reflects the anatomical units. Manometric values is specified in mmHg. For detection of passage of air and flow of liquid an impedance baseline is set before measurements start. Passage of air is defined as a sudden rise in impedance of 1 kΩ in anterograde direction. Detection of fluid is defined as a 50% decline in impedance. For analysis of data Mano View analysis software is used.
Pressures and impedance will be continuously recorded during the time frame from preoxygenation to maximum inspiratory pressures are reached. Data will be analysed at each level of pressure 3, 5, 10, 15, 20, 25 and 30 cm H2O. Contained data will be statistically compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask ventilation with PEEP | Experimental | Procedure: Mask ventilation with PEEP via a face mask device15 subjects will undergo anesthetic induction with application of PEEP of 10 cm H2O during mask ventilation. |
| Mask ventilation without PEEP | No intervention | –15 subjects will undergo anesthetic induction without PEEP during mask ventilation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female age 18-40 years
- Signed and informed consent
- Subject will and is assumed to be able to follow protocol
Key exclusion criteria (5 listed)
- Known gastro intestinal/heart/lung/kidney or neurological disease
- Use of drugs that interfere with esophageal motility
- Diabetes
- Pregnancy or breastfeeding
- BMI >30
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 |
|---|---|---|
| Mask ventilation with PEEP via a face mask device15 subjects will undergo anesthetic induction with an application of PEEP of 10 cm H2O during mask ventilation via a face mask. 15 subjects will undergo anesthetic induction without PEEP during mask ventilation via a face mask. | Procedure or surgery | Mask ventilation with PEEP |
Primary outcome
Level of inspiratory pressure for gastric insufflation
Time frame: One hour
1 secondary outcome
Pressure changes in the esophagus related to ventilation technique.
Time frame: One hour
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 5 Apr 2016.
- Derived from this study: PubMed 31116114Cajander P, Edmark L, Ahlstrand R, Magnuson A, de Leon A. Effect of positive end-expiratory pressure on gastric insufflation during induction of anaesthesia when using pressure-controlled ventilation via a face mask: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):625-632. doi: 10.1097/EJA.0000000000001016.
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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.
Alex deLeon, MD, Phd principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask ventilation with PEEP via a face mask device in people with Air Insufflation and Regurgitation, run by Örebro University, Sweden 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 3 inclusion and 5 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 5 Apr 2016. 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?
Level of inspiratory pressure for gastric insufflation (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02238691, which also lists 1 linked publication.
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 5 Apr 2016.