NCT05278923

Brief Summary

Regurgitation is an adverse event common during cardiopulmonary resuscitation (CPR) and occurs in 20%-32% of patients experiencing out-of-hospital cardiac arrest (OHCA). It can impair ventilation, induce aspiration, and decrease survival to hospital discharge. Gastric fluid in the airway obscures the laryngeal view, thereby considerably decreasing the first-pass success of endotracheal intubation (ETI) by paramedics. A human cadaver study reported that ETI outperforms other airway management devices, such as the i-gel, laryngeal mask, and laryngeal tube, in preventing aspiration when regurgitation occurs during CPR. However, ETI is also associated with multiple and prolonged CPR pauses.Compared with the use of supraglottic airway (SGA) devices, ETI results in more hands-off time during CPR. Recent randomised clinical trials have revealed that airway management with an SGA device provides superior outcomes to those of ETI in patients with OHCA. However, ETI remains the preferred management strategy for an airway affected by regurgitation in patients with OHCA. Current guidelines focus on the quality of CPR because it is a key determinant of survival in patients with OHCA. However, evidence regarding the impact of regurgitation during ETI on CPR quality is limited. This manikin simulation study assessed CPR quality during ETI in airways with and without regurgitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

May 5, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 17, 2022

Last Update Submit

April 28, 2022

Conditions

Keywords

resuscitation, Airway decontamination, suction assisted

Outcome Measures

Primary Outcomes (1)

  • chest compression fraction

    the proportion of time spent performing chest compressions during arrest

    3 hours

Secondary Outcomes (1)

  • intubation success rate

    3 hours

Study Arms (2)

clean airway

NO INTERVENTION

CPR and endotracheal intubation in an airway without regurgitation

regurgitation airway

EXPERIMENTAL

CPR and endotracheal intubation in an airway with regurgitation

Device: SALAD simulation device

Interventions

An airway CPR manikin was modified to simulate regurgitation during CPR . A manual pump was fixed on the bottom of the torso to simulate the stomach. A clear vinyl tube was connected the manikin's oesophagus and the outflow port of the pump. A water container outside the manikin was filled with simulated gastric content and connected to the inflow port of the pump through another vinyl tube. The manikin's left main bronchus was occluded using a red cap provided by the manufacturer. The lung was simulated by an anaesthesia breathing bag placed outside the manikin and connected to the manikin's right main bronchus via a breathing circuit. A compression pad was attached to the bottom of the manikin's compression plate. During chest compression, the compression pad squeezed the pump to regurgitate gastric contents into the oropharynx

regurgitation airway

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinkong Wu-Ho-Su memorial hospital

Taipei, Shih-Lin, 111, Taiwan

Location

Related Publications (28)

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    PMID: 33084397BACKGROUND
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MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Two scenarios were simulated. CPR and ETI in an airway with regurgitation (oropharyngeal regurgitation scenario) and CPR and ETI in an airway without regurgitation (clean airway scenario). All EMT-Ps were assigned to participate initially in one of the scenarios. After all EMT-Ps had finished the first scenario, they switched to the other.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 14, 2022

Study Start

July 1, 2018

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

May 5, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations