AnesthesiaSeoMaskNCT03567928
Laryngeal Mask in Upper Gastrointestinal Procedures
A study testing Sedation with Gastro Cuff Pilot Laryngeal Mask and Propofol in people with Anesthesia and Airway Device, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Airway Device, C.Surgical Procedure; Gastrointestinal
- What is being tested?
- Sedation with Gastro Cuff Pilot Laryngeal Mask and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2018to 10 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- written informed consent
- elective ERCP and endoscopic ultrasound procedure
Who cannot join
- pregnancy
- contraindication to propofol administration
- contraindication to mask insertion (e.g. malformation)
- emergency operation (not scheduled)
- preexisting causes of hypoventilation (e.g. chronic obstructive pulmonary disease, neuromuscular disease…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesiological Management of Ventilation With Laryngeal Mask in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound Procedures
Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. An example are endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.
The procedures are generally performed with deep sedation. Many pharmacologic regimens are available and described in literature. The investigator's institute adopts propofol target controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons for hypoventilation can exacerbate this event, especially in the elderly and the chronic obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a pressure support ventilation. One specific type of LMA allows to separate the gastric and respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and only if) necessary.
Read the detailed description
This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic procedures. Randomization is centralized. The study is single blind (patient). The study is no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be screened and consecutive eligible patients will be enrolled. Subjects will be allocated according to a simple randomization list. The study starts after randomization and ends after discharge from the recovery room. After peripheral venous catheter insertion and vital parameters monitoring, patients will receive propofol TCI with a tailored target between 4 and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide (ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above 50 mmHg, the patient will be supported as necessary with PSV. The control group will not receive any airway device, according to the standard treatment. At the end of the procedure, both group will receive a laboratory testing (peripheral arterial sample), when the patient is still sedated. Vital parameters monitoring will continue in recovery room. Patients will be discharge as usual with an Aldrete score > 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
- Being tested
- Sedation with Gastro Cuff Pilot Laryngeal Mask, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with Gastro Cuff Pilot Laryngeal MaskDevice
This specific type of laryngeal mask allows to separate the gastric and respiratory tract and allows the anesthesiologist to support patient's ventilation as (and only if) necessary.
PropofolDrug
Target controlled infusion (TCI) with propofol
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Standard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe) Receives: Drug: Propofol |
| Interventional Treatment | Experimental | Interventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation) Receives: Device: Sedation with Gastro Cuff Pilot Laryngeal Mask; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Pressure of Carbon Dioxide (PaCO2)
PaCO2 level assessed by arterial sample
Measured: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Secondary outcomes (7)
Number of pressure support ventilation in treatment group
Number needing pressure support ventilation (PSV) in the treatment group. A PSV will be performed in case of End-Tidal carbon dioxide level raising above 50 mmHg.
Measured: During the procedure
pH
pH assessed by arterial sample
Measured: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Partial Pressure of Oxygen (PaO2)
PaO2 level assessed by arterial sample
Measured: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Time to recover after the procedure
Time needed to recover: from arrival in recovery room to a Aldrete Score > 9
Measured: During recovery room stay (approximately 15-45 min after patient awakening)
Satisfaction of the procedure operator
Satisfaction of the operator assessed by a Likert 5 points-scale: 1 "Strongly disagree"; 2 "Disagree"; 3 " Neutral/Neither agree nor disagree"; 4 "Agree"; 5 "Strongly agree"
Measured: 1 minute after patient awakening
Satisfaction of the patient
Satisfaction of the patient assessed by a Likert 5 points-scale: 1 "Strongly disagree"; 2 "Disagree"; 3 " Neutral/Neither agree nor disagree"; 4 "Agree"; 5 "Strongly agree"
Measured: 20 minutes after patient awakening
Number of completed endoscopic procedures
Number of completed endoscopic procedures without necessity to change anesthesiological treatment or postpone the procedure for any reason
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start26 Sep 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Why it stopped: Technical problem with device in study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Model description
- Two groups: one receive sedation in spontaneous breathe, the other receive sedation with laryngeal mask
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agostoni Massimo, Ospedale San Raffaele
- Investigators
- Massimo Agostoni, MD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567928
- Sponsor's protocol ID
- 43/int/2018
- Acronym
- SeoMask
- Status last verified
- Apr 2019
- First submitted
- 17 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiological Management of Ventilation With Laryngeal Mask in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound Procedures
- ClinicalTrials.gov ID
- NCT03567928
- Acronym / sponsor ID
- SeoMask / 43/int/2018
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical problem with device in study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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.
Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. An example are endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.
The procedures are generally performed with deep sedation. Many pharmacologic regimens are available and described in literature. The investigator's institute adopts propofol target controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons for hypoventilation can exacerbate this event, especially in the elderly and the chronic obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a pressure support ventilation. One specific type of LMA allows to separate the gastric and respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and only if) necessary.
Detailed description
This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic procedures. Randomization is centralized. The study is single blind (patient). The study is no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be screened and consecutive eligible patients will be enrolled. Subjects will be allocated according to a simple randomization list. The study starts after randomization and ends after discharge from the recovery room. After peripheral venous catheter insertion and vital parameters monitoring, patients will receive propofol TCI with a tailored target between 4 and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide (ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above 50 mmHg, the patient will be supported as necessary with PSV. The control group will not receive any airway device, according to the standard treatment. At the end of the procedure, both group will receive a laboratory testing (peripheral arterial sample), when the patient is still sedated. Vital parameters monitoring will continue in recovery room. Patients will be discharge as usual with an Aldrete score > 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: one receive sedation in spontaneous breathe, the other receive sedation with laryngeal mask
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: PropofolStandard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe) |
| Interventional Treatment | Experimental | Device: Sedation with Gastro Cuff Pilot Laryngeal Mask, Drug: PropofolInterventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18 years
- written informed consent
- elective ERCP and endoscopic ultrasound procedure
Key exclusion criteria (5 listed)
- pregnancy
- contraindication to propofol administration
- contraindication to mask insertion (e.g. malformation)
- emergency operation (not scheduled)
- preexisting causes of hypoventilation (e.g. chronic obstructive pulmonary disease, neuromuscular 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 |
|---|---|---|
| Sedation with Gastro Cuff Pilot Laryngeal MaskThis specific type of laryngeal mask allows to separate the gastric and respiratory tract and allows the anesthesiologist to support patient's ventilation as (and only if) necessary. | Device | Interventional Treatment |
| PropofolTarget controlled infusion (TCI) with propofol | Drug | Interventional Treatment, Standard Treatment |
Primary outcome
Partial Pressure of Carbon Dioxide (PaCO2)
Time frame: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
PaCO2 level assessed by arterial sample
7 secondary outcomes
Number of pressure support ventilation in treatment group
Time frame: During the procedure
pH
Time frame: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Partial Pressure of Oxygen (PaO2)
Time frame: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Time to recover after the procedure
Time frame: During recovery room stay (approximately 15-45 min after patient awakening)
Satisfaction of the procedure operator
Time frame: 1 minute after patient awakening
Satisfaction of the patient
Time frame: 20 minutes after patient awakening
Number of completed endoscopic procedures
Time frame: During the procedure
Results and safety
The study was stopped early (reason given: Technical problem with device in study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Massimo Agostoni, MD principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation with Gastro Cuff Pilot Laryngeal Mask and Propofol in people with Anesthesia and Airway Device, run by Ospedale San Raffaele at 1 site in Italy.
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: stopped early, as of the sponsor's last update on 16 Apr 2019. 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 Italy. 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 was stopped early (reason given: Technical problem with device in study). Results are not available in the source record.
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?
Partial Pressure of Carbon Dioxide (PaCO2) (time frame: Just before patient awakening (approximately 90-120 min after induction of 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 16 Apr 2019.