NCT07380607

Brief Summary

This observational study examined double triggering asynchrony in28ICU patients on mechanical ventilation. Researchers collected data on patient characteristics, health conditions, and outcomes to understand how this problem affects critically ill patients. Findings may help improve ventilator care in intensive care units.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

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

November 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

April 15, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

January 17, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Double TriggeringPatient-Ventilator AsynchronyDiaphragmatic UltrasoundMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of diaphragmatic ultrasound for detection of double triggering asynchrony

    Proportion of double triggering asynchrony events correctly identified by diaphragmatic ultrasound compared with ventilator waveform analysis as the reference standard

    During ICU admission, at the time of double triggering detection by ventilator graph interpretation

Study Arms (1)

Double Triggering Cohort

28mechanically ventilated ICU patients identified with double triggering asynchrony

Eligibility Criteria

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

Adult patients (\>18 years) admitted to medical/surgical ICU at Specialized Medical Hospital, Mansoura University, receiving invasive mechanical ventilation with documented double triggering asynchrony on ventilator waveform analysis.

You may qualify if:

  • Adult ICU patients aged ≥18 years receiving invasive mechanical ventilation
  • Documented double triggering asynchrony on ventilator waveform analysis.

You may not qualify if:

  • Patients with contraindications to diaphragmatic ultrasound, including thoracic or abdominal surgery.
  • Patients with known diseases affecting diaphragmatic function, such as Duchenne muscular dystrophy (DMD) or myasthenia gravis (MG).
  • Patients with advanced chronic liver disease (Child-Pugh class C)
  • Patients with chronic increased intra-abdominal pressure.
  • Patients with moderate to massive pleural effusion.
  • Patient or legal guardian refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialised Medical Hospital - ICU

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Respiratory InsufficiencyCritical IllnessPatient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2026

First Posted

February 2, 2026

Study Start

November 5, 2024

Primary Completion

October 20, 2025

Study Completion

November 2, 2025

Last Updated

April 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations