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Airway AspirationNCT06427655

Benefit of the SALAD Technique on CPR Quality During Intubation in Contaminated Airway

A study testing SALAD intubation in people with Airway Aspiration and Cardiopulmonary Arrest, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Management of airways in contaminated environments can compromise the quality of cardiopulmonary resuscitation (CPR). This study examined the effectiveness of SALAD (Suction Assisted Laryngoscopy Airway Decontamination) compared to intermittent suction in maintaining CPR quality during intubation in a simulated… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Airway Aspiration, Cardiopulmonary Arrest
What is being tested?
SALAD intubation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTaiwan
Study dates
1 Jan 2024to 31 Mar 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • emergency medical technician-paramedics experienced in advanced airway management and CPR

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Shinkong Wu-Ho-Su memorial hospital

    Taipei, Shih-Lin, 111

Other trials in Taiwan

About this study

Management of airways in contaminated environments can compromise the quality of cardiopulmonary resuscitation (CPR). This study examined the effectiveness of SALAD (Suction Assisted Laryngoscopy Airway Decontamination) compared to intermittent suction in maintaining CPR quality during intubation in a simulated scenario of regurgitation. Following 2.5 hours of training in the SALAD technique, 36 emergency medicaltechnician-paramedics (EMT-Ps) were randomly assigned in equal numbers to two groups: one utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin. The manikin simulates regurgitation of gastric contents into the oropharynx during CPR. Primary outcomes assessed were CPR quality metrics, such as chest compression rate, depth, and interruption. Secondary outcomes included the success rate and time of intubation.

Read the detailed description

The study was conducted in March 2024. Participants were emergency medical technician-paramedics (EMT-Ps) employed by fire departments across Taiwan, recruited on a nationwide basis. All participants provided signed informed consent forms. 36 EMT-Ps are involved in this study.

Simulation setup :

The CPR-induced regurgitation model was adapted from an Airway Larry Airway Management Trainer Torso (Nasco, Fort Atkinson, WI, USA) to simulate oropharyngeal regurgitation during CPR. To emulate the stomach, a manual pump was attached at the base of the manikin's torso. A transparent vinyl tube connected the manikin's esophagus to the pump's outlet port. A HQCPR device was used for CPR quality record.

Training program The 36 participants received 2.5 hours of SALAD training. The training included 5 rounds of intubation teaching and practice. The first two rounds of training involve using the SALAD technique with the video laryngoscope, while the third round used the C-MAC S video laryngoscope as a direct laryngoscope for practice. Technique adjustments can be made during the initial three rounds through monitoring with the video system. The fourth round will involve intubation using a direct laryngoscope with a size 3 Macintosh blade on the SALAD Simulator. The final round involved intubation on the CPR-induced regurgitation model, using a direct laryngoscope and employing the SALAD technique for intubation during chest compressions.

Simulation protocol After completing 2.5 hours of training, participants were randomly assigned to one of two groups for suction techniques: SALAD or intermittent suction. Randomization was conducted using the simple randomization method with a random number table. Participants assigned to the same suction technique group formed a resuscitation team, taking on roles as the airway manager, first chest compressor, or second chest compressor. Each participant rotated through these three roles during three simulation sessions.In each simulation, the airway manager was responsible for BVM ventilation and intubation. The first and second chest compressors performed chest compressions alternately, once every five CPR cycles, adhering to a 30:2 compression-to- ventilation ratio. The initial 30 chest compressions were followed by two ventilations, and suction was not performed during this phase, even if regurgitation was present. This was intended to simulate a scenario where the oral cavity was filled with regurgitant material during intubation, maintaining consistency across participants. After the first two ventilations, intubation could proceed while the team continued chest compressions. The airway manager could request a temporary reduction, lightening, or even cessation of chest compressions to facilitate intubation, or to continue up to 60 compressions without interruption if necessary. If the intubation attempt was unsuccessful, the airway manager had to administer two BVM ventilations before attempting intubation again. Depending on the group assignment, either SALAD or intermittent suction techniques were employed to assist in airway decontamination. After intubation, the airway manager assessed lung expansion using the BVM to verify successful intubation. A failed intubation was defined as any esophageal intubation or three unsuccessful intubation attempts. Each simulation concluded following either a successful or failed intubation.

Measurement The primary outcomes were CPR quality metrics, including chest compression rate, chest compression depth, and time of interruption. The secondary outcomes were the intubation success rate and intubation time. The rate and depth of the first 30 chest compressions (pre-intubation period) were measured. After the initial 30 compressions, interruptions for ventilation or airway management, as well as the quality of chest compressions during intubation, were also measured (intubation period). An intubation attempt was defined as the insertion of the laryngoscope blade into the mouth and its subsequent withdrawal during an unsuccessful attempt, or as the insertion of the laryngoscope blade followed by confirmation from the airway manager that the tube was inserted. Intubation time was defined as the period between the start and the end of an intubation attempt. Two video cameras were set up to record the entire simulation process. Two observers reviewed the video records independently to identify any intubation attempts. Disagreements were resolved by reaching a mutual consensus.

The HQCPR application on an Android device recorded chest compression depth, rate, and interruptions (defined as no chest compression for more than 1 second).

The data from both the video recordings and the HQCPR application were used in subsequent analyses.

Statistical analysis The characteristics of EMT-Ps were described using frequency and percentage for categorical variables, while mean values with standard deviation (SD) were used for continuous variables. Continuous data were compared using the independent t-test between the SALAD and intermittent suction groups, while categorical data were compared using the Fisher's exact test or the Chi-Squared test between these two groups. CPR quality metrics and intubation time were summarized using mean values with 95% confidence intervals (CI). Compression depth greater than or equal to 5 cm, first-pass intubation success, and esophageal intubation were presented as frequency and percentage. Continuous data were compared using the independent t test between the SALAD and intermittent suction groups, while categorical data were compared using Fisher's exact test between these two groups. CPR quality metrics between the pre-intubation period and the intubation period were analyzed using the paired t test in both the SALAD and intermittent suction groups. A two- tailed p-value of less than 0.05 indicated statistical significance. All data analyses and sample size determination were performed using MedCalc Statistical Software version 22.023 (MedCalc Software, Ostend, Belgium).

Being tested
SALAD intubation
Keywords
airway decontamination, suction assisted, resuscitation, cardiopulmonary resuscitation quality
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SALAD intubationDevice

    SALAD suction during intubation

Study groups in NCT06427655
Study groupRoleWhat they receive
intermittent suctionNo interventionintermittent suction during intubation
SALADExperimentalSALAD suction during intubation
Receives: Device: SALAD intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. chest compression fraction

    the proportion of time spent performing chest compressions during arrest

    Measured: 3 hour

Secondary outcomes (1)
  1. success rate of intubation

    the rate of successful intubation

    Measured: 3 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Crossover
Model description
Participants were randomized into two groups. One group utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin.
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427655
Sponsor's protocol ID
20220903R
Status last verified
May 2024
First submitted
12 May 2024
Last updated
24 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Simons RW, Rea TD, Becker LJ, Eisenberg MS. The incidence and significance of emesis associated with out-of-hospital cardiac arrest. Resuscitation. 2007 Sep;74(3):427-31. doi: 10.1016/j.resuscitation.2007.01.038. Epub 2007 Apr 11.

    PubMed 17433526
  • Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597.

    PubMed 30167701
  • Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.

    PubMed 19573949
  • Ruetzler K, Gruber C, Nabecker S, Wohlfarth P, Priemayr A, Frass M, Kimberger O, Sessler DI, Roessler B. Hands-off time during insertion of six airway devices during cardiopulmonary resuscitation: a randomised manikin trial. Resuscitation. 2011 Aug;82(8):1060-3. doi: 10.1016/j.resuscitation.2011.03.027. Epub 2011 Apr 6.

    PubMed 21514986
  • Wang HE, Jaureguibeitia X, Aramendi E, Jarvis JL, Carlson JN, Irusta U, Alonso E, Aufderheide T, Schmicker RH, Hansen ML, Huebinger RM, Colella MR, Gordon R, Suchting R, Idris AH. Airway strategy and chest compression quality in the Pragmatic Airway Resuscitation Trial. Resuscitation. 2021 May;162:93-98. doi: 10.1016/j.resuscitation.2021.01.043. Epub 2021 Feb 11.

    PubMed 33582258
  • Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.

    PubMed 30167699
  • Piegeler T, Roessler B, Goliasch G, Fischer H, Schlaepfer M, Lang S, Ruetzler K. Evaluation of six different airway devices regarding regurgitation and pulmonary aspiration during cardio-pulmonary resuscitation (CPR) - A human cadaver pilot study. Resuscitation. 2016 May;102:70-4. doi: 10.1016/j.resuscitation.2016.02.017. Epub 2016 Feb 26.

    PubMed 26921473
  • Lin LW, DuCanto J, Hsu CY, Su YC, Huang CC, Hung SW. Compromised cardiopulmonary resuscitation quality due to regurgitation during endotracheal intubation: a randomised crossover manikin simulation study. BMC Emerg Med. 2022 Jul 9;22(1):124. doi: 10.1186/s12873-022-00662-0.

    PubMed 35810275
  • DuCanto J, Serrano KD, Thompson RJ. Novel Airway Training Tool that Simulates Vomiting: Suction-Assisted Laryngoscopy Assisted Decontamination (SALAD) System. West J Emerg Med. 2017 Jan;18(1):117-120. doi: 10.5811/westjem.2016.9.30891. Epub 2016 Nov 8.

    PubMed 28116021
  • Lin LW, Huang CC, Ong JR, Chong CF, Wu NY, Hung SW. The suction-assisted laryngoscopy assisted decontamination technique toward successful intubation during massive vomiting simulation: A pilot before-after study. Medicine (Baltimore). 2019 Nov;98(46):e17898. doi: 10.1097/MD.0000000000017898.

    PubMed 31725637
  • Pilbery R, Teare MD. Soiled airway tracheal intubation and the effectiveness of decontamination by paramedics (SATIATED): a randomised controlled manikin study. Br Paramed J. 2019 Jun 1;4(1):14-21. doi: 10.29045/14784726.2019.06.4.1.14.

    PubMed 33328824
  • Fiore MP, Marmer SL, Steuerwald MT, Thompson RJ, Galgon RE. Three Airway Management Techniques for Airway Decontamination in Massive Emesis: A Manikin Study. West J Emerg Med. 2019 Aug 6;20(5):784-790. doi: 10.5811/westjem.2019.6.42222.

    PubMed 31539335
  • Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.

    PubMed 26472993
  • Agostinucci JM, Weisslinger L, Marzouk N, Zouaghi H, Ekpe K, Genthillomme A, Adnet F, Guenin A, Reuter PG, Lapostolle F. Relation between chest compression rate and depth: the ENFONCE Study. Eur J Emerg Med. 2021 Oct 1;28(5):352-354. doi: 10.1097/MEJ.0000000000000802.

    PubMed 33758145
  • McAlister O, Harvey A, Currie H, McCartney B, Adgey J, Owens P, Idris A. Temporal analysis of continuous chest compression rate and depth performed by firefighters during out of hospital cardiac arrest. Resuscitation. 2023 Apr;185:109738. doi: 10.1016/j.resuscitation.2023.109738. Epub 2023 Feb 16.

    PubMed 36806652

Questions about this trial

What is this clinical trial studying?

A study testing SALAD intubation in people with Airway Aspiration and Cardiopulmonary Arrest, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

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 1 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 24 May 2024. 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 Taiwan. 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?

chest compression fraction (time frame: 3 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 NCT06427655, which also lists 26 linked publications.

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 24 May 2024.

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