Anesthesia Intubation ComplicationNCT03239236
Modified Rapid Sequence Induction in Morbidly Obese Patients
A study testing Rapid sequence induction t-RSI, Rapid sequence induction m-RSI-PEEP and Rapid sequence induction m-RSI-vent in people with Anesthesia Intubation Complication, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Rapid sequence induction t-RSI, Rapid sequence induction m-RSI-PEEP and Rapid sequence induction m-RSI-vent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2021to Feb 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 40
- American Society of Anesthesiology Class 1-3
- Elective laparoscopic surgery
Who cannot join
- Pregnant or breastfeeding patients
- Previous bariatric surgery
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.
Read the detailed description
100 adult patients with a body mass index > 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded.
The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.
All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy.
In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between.
Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed.
Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with additional pressure support of 8 mbar and a back up ventilation frequency will be set to 10/min. After the same induction agents are given as in group 1, patients will receive non-invasive ventilation via ventilator at the settings described earlier for group 3.
Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be applied during the non invasive ventilation.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Rapid sequence induction t-RSI, Rapid sequence induction m-RSI-PEEP, Rapid sequence induction m-RSI-vent, m-RSI-vent-cric, Cricoid Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid sequence induction t-RSIProcedure or surgery
Preoxygenation via face mask, no ventilation with no PEEP until intubation
Rapid sequence induction m-RSI-PEEPProcedure or surgery
Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Rapid sequence induction m-RSI-ventProcedure or surgery
Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
m-RSI-vent-cricProcedure or surgery
Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Cricoid PressureProcedure or surgery
Cricoid Pressure will be applied during RSI until laryngoscopy
AnestheticsDrug
Also called Induction Agents
Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight).
Aspiration of gastric air via nasogastric tubeDiagnostic test
A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
Impression of gastric inflation at laparoscopy.Diagnostic test
The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.
Arterial blood gasDiagnostic test
Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated.
| Study group | Role | What they receive |
|---|---|---|
| t-RSI | Experimental | Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points. Receives: Procedure: Rapid sequence induction t-RSI; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas |
| m-RSI-PEEP | Experimental | Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points. Receives: Procedure: Rapid sequence induction m-RSI-PEEP; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas |
| m-RSI-vent | Experimental | Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points. Receives: Procedure: Rapid sequence induction m-RSI-vent; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas |
| m-RSI-vent-cric | Experimental | Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points. Receives: Procedure: m-RSI-vent-cric; Procedure: Cricoid Pressure; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of air aspirated with a gastric tube
The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
Measured: at the beginning of the laparoscopy
Secondary outcomes (2)
Gastric inflation
The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded. These images will afterwards be reviewed in a blinded fashion by three different investigators. The investigators will rate their impression of gastric inflation (empty, mildly inflated, inflated, very inflated).
Measured: at the beginning of laparoscopy
partial pressure of oxygen in arterial blood (paO2)
Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, after intubation.
Measured: before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study startFeb 2021 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: no funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hamp, Medical University of Vienna
- Investigators
- Walter Plöchl, Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239236
- Sponsor's protocol ID
- Modified RSI in morbidly obese
- Status last verified
- Feb 2021
- First submitted
- 16 Jun 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Rapid Sequence Induction in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT03239236
- Acronym / sponsor ID
- Modified RSI in morbidly obese
- Conditions
- Anesthesia Intubation Complication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 4 Aug 2017 (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.
This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.
Detailed description
100 adult patients with a body mass index > 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded.
The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.
All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy.
In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between.
Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed.
Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with additional pressure support of 8 mbar and a back up ventilation frequency will be set to 10/min. After the same induction agents are given as in group 1, patients will receive non-invasive ventilation via ventilator at the settings described earlier for group 3.
Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be applied during the non invasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| t-RSI | Experimental | Procedure: Rapid sequence induction t-RSI, Drug: Anesthetics, Diagnostic Test: Aspiration of gastric air via nasogastric tube, Diagnostic Test: Impression of gastric inflation at laparoscopy., Diagnostic Test: Arterial blood gasRapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-PEEP | Experimental | Procedure: Rapid sequence induction m-RSI-PEEP, Drug: Anesthetics, Diagnostic Test: Aspiration of gastric air via nasogastric tube, Diagnostic Test: Impression of gastric inflation at laparoscopy., Diagnostic Test: Arterial blood gasRapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-vent | Experimental | Procedure: Rapid sequence induction m-RSI-vent, Drug: Anesthetics, Diagnostic Test: Aspiration of gastric air via nasogastric tube, Diagnostic Test: Impression of gastric inflation at laparoscopy., Diagnostic Test: Arterial blood gasRapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-vent-cric | Experimental | Procedure: m-RSI-vent-cric, Procedure: Cricoid Pressure, Drug: Anesthetics, Diagnostic Test: Aspiration of gastric air via nasogastric tube, Diagnostic Test: Impression of gastric inflation at laparoscopy., Diagnostic Test: Arterial blood gasRapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 40
- American Society of Anesthesiology Class 1-3
- Elective laparoscopic surgery
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding patients
- Previous bariatric surgery
- Anticipated difficult airway
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 |
|---|---|---|
| Rapid sequence induction t-RSIPreoxygenation via face mask, no ventilation with no PEEP until intubation | Procedure or surgery | t-RSI |
| Rapid sequence induction m-RSI-PEEPPreoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation. | Procedure or surgery | m-RSI-PEEP |
| Rapid sequence induction m-RSI-ventPreoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation. | Procedure or surgery | m-RSI-vent |
| m-RSI-vent-cricPreoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation. | Procedure or surgery | m-RSI-vent-cric |
| Cricoid PressureCricoid Pressure will be applied during RSI until laryngoscopy | Procedure or surgery | m-RSI-vent-cric |
| AnestheticsAlso: Induction AgentsInduction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight). | Drug | m-RSI-PEEP, m-RSI-vent, m-RSI-vent-cric, t-RSI |
| Aspiration of gastric air via nasogastric tubeA nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml. | Diagnostic test | m-RSI-PEEP, m-RSI-vent, m-RSI-vent-cric, t-RSI |
| Impression of gastric inflation at laparoscopy.The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded. | Diagnostic test | m-RSI-PEEP, m-RSI-vent, m-RSI-vent-cric, t-RSI |
| Arterial blood gasArterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated. | Diagnostic test | m-RSI-PEEP, m-RSI-vent, m-RSI-vent-cric, t-RSI |
Primary outcome
Amount of air aspirated with a gastric tube
Time frame: at the beginning of the laparoscopy
The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
2 secondary outcomes
Gastric inflation
Time frame: at the beginning of laparoscopy
partial pressure of oxygen in arterial blood (paO2)
Time frame: before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Walter Plöchl, Professor principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid sequence induction t-RSI, Rapid sequence induction m-RSI-PEEP and Rapid sequence induction m-RSI-vent in people with Anesthesia Intubation Complication, run by Medical University of Vienna at 1 site in Austria.
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 3 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: withdrawn, as of the sponsor's last update on 18 Feb 2021. 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 Austria. 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 withdrawn before enrolling participants, so there are no results.
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?
Amount of air aspirated with a gastric tube (time frame: at the beginning of the laparoscopy). 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 18 Feb 2021.