NCT06791317

Brief Summary

This retrospective study aims to explore whether the introduction of a preprocedural checklist for intubation in the intensive care unit (ICU) is associated with a lower incidence of intubation-related complications. Using a database where protocols from intubations in the ICU before implementing a checklist and after we will investigate whether a checklist affects early desaturation and hypotension after intubation.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

January 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 15, 2025

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Level of desaturation

    \- Peripheral oxygen saturation (SpO2) below 90% (or \>5% drop if saturation is \<90% after preoxygenation).

    From intubation up to 5 minutes after the procedure

  • Level of lowering blood pressure

    A systolic arterial pressure (SAP) below 90 mmHg

    From intubation up to 5 minutes after the procedure

Secondary Outcomes (11)

  • 30-day mortality

    30 days

  • Ventilator days

    30 days

  • Days in the intensive care unit

    3 months

  • Number of intubation attempts

    1 hour

  • First-pass success rate

    1 hour

  • +6 more secondary outcomes

Study Arms (2)

Standard care

Intubation procedure before introduction of a checklist

Other: Checklist

Checklist group

Intubation procedure after introduction of a checklist

Other: Checklist

Interventions

A checklist for the intubation procedure was organised into the categories physiological optimisation, equipment and drugs, team line-up, and contingency plan. This checklist was implemented in the clinic.

Checklist groupStandard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intensive Care Patients that undergo tracheal intubation. All patients (before and after checklist) are registered with a protocol during intubation. This protocol is registered in a Respiratory Database.

You may qualify if:

  • Patient in the ICU
  • Need for tracheal intubation

You may not qualify if:

  • Pateint is under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Perioperative Medicine and Intensive Care

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Nejatian A, Forsberg IM, Thoro U, Sjoblom A, Kahlin J. Impact of Checklist Implementation on Endotracheal Intubation-Related Complications in Critically Ill Adults-A Retrospective Before and After Study. Acta Anaesthesiol Scand. 2025 Aug;69(7):e70103. doi: 10.1111/aas.70103.

MeSH Terms

Conditions

Critical IllnessRespiratory InsufficiencyUnconsciousness

Interventions

Checklist

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research group leader

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 24, 2025

Study Start

January 15, 2025

Primary Completion

February 15, 2025

Study Completion

May 15, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

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