RSINCT06667336
The Impact of Suctioning on Oxygenation During RSI in the Emergency Department
A study testing intermittent suction and continuous suction in people with RSI, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Rapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and has been associated with significant complications including hypoxia, hypotension, airway trauma, aspiration, and death. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- RSI
- What is being tested?
- intermittent suction and continuous suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 28 Oct 2024
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency Medicine Patients
- Requiring Rapid Sequence Intubation in the Resuscitation Bay
- 18 years+
Who cannot join
- Patients that have a heavily soiled airway (i.e. secretions, vomitus, blood)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Suctioning on Oxygenation During RSI in the Emergency Department-A Multi-Center Pilot Study
Rapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and has been associated with significant complications including hypoxia, hypotension, airway trauma, aspiration, and death. Specifically, hypoxic episodes during intubation can lead to poor outcomes such as dysrhythmias, haemodynamic compromise, hypoxic brain injury and cardiac arrest, and is therefore of primary concern during any intubation procedure. Aspiration is a serious adverse event and potential cause of hypoxia during RSI and can lead to poor patient outcomes downstream of the procedure. The reported incidence of aspiration during RSI in the ED ranges from 3 to 8% in the ED population. In order to achieve an optimal view of the glottis and prevent pulmonary aspiration of fluids in the oropharynx, providers apply suction prior to and during laryngoscopy, using a Yankauer or large-bore suction catheter.
There is currently significant variation in suctioning during laryngoscopy, with some providers using very little suction as needed to clear heavy fluids (judicious suctioning), while others utilise suction aggressively (lead with suction) and as a part of their routine laryngoscopy technique. Evidence suggests inline suction on already-intubated patients accelerates desaturation, but we are aware of no studies examining the impact suctioning has on the speed of desaturation during emergent endotracheal intubation.
This pilot study aims to compare the effects of intermittent, as-needed "judicious" suctioning versus aggressive "continuous" (lead with) suctioning on oxygenation during rapid sequence intubation in the emergency department.
Read the detailed description
Intervention
The aim of this study is to investigate the effect of suctioning (a current technique used conventionally in RSI) on oxygenation levels during RSI. This being noted, there is no new intervention being applied to the patient.
In order to investigate this, the current standard of care of suctioning will be used either by judicious means (i.e. in and out suction as needed) or continuous means (i.e. throughout the procedure, including laryngoscopy and tube placement) according to conventional practice at the discretion of the treating physician. For all patients involved in the study, there will be no new intervention applied. The impact of the use of suctioning, again which is standard of care and applied by convention, will be determined by measuring oxygen saturation as a primary outcome. All aspects of RSI will be at the discretion of the treating clinician, which is the current standard, including induction/relaxant medication, positioning of the patient, preoxygenation method, method of intubation and post-intubation sedation. At all institutions RSI is performed in a similar manner utilising an airway checklist (Appendix 1 and 2). However, there are no 'Standard Operating Procedures' for RSI in any ED and therefore intubation technique will vary depending on clinician preference and the clinical circumstances.
Once the decision to perform RSI has been made by the treating team, the patient will be enrolled into either a judicious or continuous suction group at random. In either case, suctioning will be applied to the patient as determined necessary by the clinician. Rapid sequence intubation will then be performed in the standard means by the treating provider.
Data Collection
The data will be collected prospectively during the time of RSI by nursing and medical staff with the use of a data collection sheet. Staff at RPA ED are familiar with the data collection sheets as prior studies in relation to RSI have been performed previously (Study number Re: X12- 0394). Similarly, staff at Lincoln Medical Center and Mount Sinai perform routine data collection on all RSI's performed in the ED for quality improvement purposes.
- Conditions
- RSI
- Being tested
- intermittent suction, continuous suction
- Keywords
- RSI, Emergency Department, Resuscitation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent suctionProcedure or surgery
This suction was applied only as needed to clear secretions
continuous suctionProcedure or surgery
The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Suction | Active comparator | This suction was applied only as needed to clear secretions Receives: Procedure: intermittent suction |
| Continuous Suction | Active comparator | The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery Receives: Procedure: continuous suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation achieved (SpO2)
the oxygen saturation achieved (SpO2) at the time of tube placement (via confirmation with first ETCO2 waveform) achieved during the intubation period.
Measured: 10 minutes
Secondary outcomes (6)
Incidence of Desaturation
Incidence of desaturation (SaO2 <90%) or >10 points from baseline during the intubation period
Measured: 2 minutes
Lowest O2 Saturation
Lowest O2 saturations at any point during the intubation period
Measured: 2 minutes
End-Tidal Oxygen Concentration ( ETO2)
The ETO2 at induction and at Endotracheal Tube (ETT) confirmation.
Measured: 2 minutes
Time from Preoxygenation
Time from preoxygenation to endotracheal intubation
Measured: 5 minutes
Complications During RSI
Complications during RSI: bradycardia, tachycardia, hypotension, hypertension, oesophageal intubation, aspiration, airway or dental trauma, equipment or medication error
Measured: 1 minute
Intubation Attempts
Number of intubation attempts
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Sep 2021
- Primary completion31 May 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSIStudies 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667336
- Sponsor's protocol ID
- 2020-01-32
- Status last verified
- Jan 2025
- First submitted
- 28 Oct 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Suctioning on Oxygenation During RSI in the Emergency Department-A Multi-Center Pilot Study
- ClinicalTrials.gov ID
- NCT06667336
- Acronym / sponsor ID
- 2020-01-32
- Conditions
- RSI
- Keywords
- RSI, Emergency Department, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 31 Oct 2024 (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.
Rapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and has been associated with significant complications including hypoxia, hypotension, airway trauma, aspiration, and death. Specifically, hypoxic episodes during intubation can lead to poor outcomes such as dysrhythmias, haemodynamic compromise, hypoxic brain injury and cardiac arrest, and is therefore of primary concern during any intubation procedure. Aspiration is a serious adverse event and potential cause of hypoxia during RSI and can lead to poor patient outcomes downstream of the procedure. The reported incidence of aspiration during RSI in the ED ranges from 3 to 8% in the ED population. In order to achieve an optimal view of the glottis and prevent pulmonary aspiration of fluids in the oropharynx, providers apply suction prior to and during laryngoscopy, using a Yankauer or large-bore suction catheter.
There is currently significant variation in suctioning during laryngoscopy, with some providers using very little suction as needed to clear heavy fluids (judicious suctioning), while others utilise suction aggressively (lead with suction) and as a part of their routine laryngoscopy technique. Evidence suggests inline suction on already-intubated patients accelerates desaturation, but we are aware of no studies examining the impact suctioning has on the speed of desaturation during emergent endotracheal intubation.
This pilot study aims to compare the effects of intermittent, as-needed "judicious" suctioning versus aggressive "continuous" (lead with) suctioning on oxygenation during rapid sequence intubation in the emergency department.
Detailed description
Intervention
The aim of this study is to investigate the effect of suctioning (a current technique used conventionally in RSI) on oxygenation levels during RSI. This being noted, there is no new intervention being applied to the patient.
In order to investigate this, the current standard of care of suctioning will be used either by judicious means (i.e. in and out suction as needed) or continuous means (i.e. throughout the procedure, including laryngoscopy and tube placement) according to conventional practice at the discretion of the treating physician. For all patients involved in the study, there will be no new intervention applied. The impact of the use of suctioning, again which is standard of care and applied by convention, will be determined by measuring oxygen saturation as a primary outcome. All aspects of RSI will be at the discretion of the treating clinician, which is the current standard, including induction/relaxant medication, positioning of the patient, preoxygenation method, method of intubation and post-intubation sedation. At all institutions RSI is performed in a similar manner utilising an airway checklist (Appendix 1 and 2). However, there are no 'Standard Operating Procedures' for RSI in any ED and therefore intubation technique will vary depending on clinician preference and the clinical circumstances.
Once the decision to perform RSI has been made by the treating team, the patient will be enrolled into either a judicious or continuous suction group at random. In either case, suctioning will be applied to the patient as determined necessary by the clinician. Rapid sequence intubation will then be performed in the standard means by the treating provider.
Data Collection
The data will be collected prospectively during the time of RSI by nursing and medical staff with the use of a data collection sheet. Staff at RPA ED are familiar with the data collection sheets as prior studies in relation to RSI have been performed previously (Study number Re: X12- 0394). Similarly, staff at Lincoln Medical Center and Mount Sinai perform routine data collection on all RSI's performed in the ED for quality improvement purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Suction | Active comparator | Procedure: intermittent suctionThis suction was applied only as needed to clear secretions |
| Continuous Suction | Active comparator | Procedure: continuous suctionThe suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency Medicine Patients
- Requiring Rapid Sequence Intubation in the Resuscitation Bay
- 18 years+
Key exclusion criteria (1 listed)
- Patients that have a heavily soiled airway (i.e. secretions, vomitus, blood)
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 |
|---|---|---|
| intermittent suctionThis suction was applied only as needed to clear secretions | Procedure or surgery | Intermittent Suction |
| continuous suctionThe suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery. | Procedure or surgery | Continuous Suction |
Primary outcome
Oxygen saturation achieved (SpO2)
Time frame: 10 minutes
the oxygen saturation achieved (SpO2) at the time of tube placement (via confirmation with first ETCO2 waveform) achieved during the intubation period.
6 secondary outcomes
Incidence of Desaturation
Time frame: 2 minutes
Lowest O2 Saturation
Time frame: 2 minutes
End-Tidal Oxygen Concentration ( ETO2)
Time frame: 2 minutes
Time from Preoxygenation
Time frame: 5 minutes
Complications During RSI
Time frame: 1 minute
Intubation Attempts
Time frame: 1 minute
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 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for RSI
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome
Cubital Tunnel Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent suction and continuous suction in people with RSI, run by Maimonides Medical Center at 1 site in United States.
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 1 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 Jan 2025. 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 United States. 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?
Oxygen saturation achieved (SpO2) (time frame: 10 minutes). 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 Jan 2025.