NCT05875662

Brief Summary

Background: Fiber bronchoscopy is a routine operation in intensive care unit (ICU), but it may cause local collapse of the lung. Recruitment maneuver (RM) after fiber bronchoscopy may have the potential to restore functional residual air volume and increase lung volume. However, there is still a lack of quantitative indicators to evaluate the effect of recruitment maneuver. With electrical impedance tomography (EIT), we can monitor lung ventilation in real time to understand the situation of lung ventilation. Objective: To evaluate whether recruitment maneuver after fiber bronchoscopy can improve lung volume and improve lung ventilation, and which people are most likely to benefit from it, by monitoring the end expiratory pulmonary impedance of critically ill patients undergoing bedside fiber bronchoscopy to monitor the lung ventilation before and after the operation and before and after recruitment maneuver. Study Design: A prospective observational study was conducted to monitor the end expiratory lung impedance (EELI), tidal impedance variable (TIV), global inhomogeneity (GI) index and Center of Ventilation (CoV) before and after bronchoscopy and recruitment maneuver, and then to understand the changes of lung volume and ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

May 7, 2023

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The change in end-expiratory lung impedance (ΔEELI)

    EIT was performed with a PulmoVista 500(Drager Medical, Lübeck, Germany).The signals were recorded and later reviewed offline using a dedicated software program (Dräger Medical GmbH EIT data analysis version 6.3).ΔEELI refers to differences in end-expiration lung impedance between 5 minutes before and 5 minutes after lung recruitment maneuver.

    Changes in EELI within 5 minutes before and 5 minutes after lung recruitment maneuver

  • The change in tidal impedance variable (ΔTIV)

    TIV, which correlates with gas volume changes in the lung, was calculated by selecting 10 subsequent breathing cycles from the recorded EIT sequences. Thereafter, differences in global impedance between end-inspiration and end-expiration were calculated, then averaged.ΔTIV is the change in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver

    Changes in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver

Study Arms (1)

Mechanical ventilation patients undergoing fiberoptic bronchoscopy

After being included in the patient, the EIT chest strap was worn to measure the end expiratory lung impedance and tidal impedance variable, assess the distribution of lung ventilation in patients and record GI index and CoV. EELI,TIV, GI index, CoV, vital signs of patients, including heart rate, blood pressure, respiratory rate, SpO2, ventilator parameters, including mode, driving pressure, FiO2, PEEP, and lung compliance was recorded before and after bronchoscopy. Patients underwent a recruitment maneuver 5 minutes after bronchoscopy maintaining breaths at a PC of 40 cm H2O with PEEP of 20 cm H2O in pressure control mode for 1 minute, then, PEEP was decreased from 20 to preceding PEEP value in steps of 2 cm H2O with a duration of at least 10 breaths or 30 seconds at each step.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Invasive mechanical ventilation patients admitted to the ICU who plan to undergo bedside fiberoptic bronchoscopy

You may qualify if:

  • Patients with invasive mechanical ventilation undergoing fiberoptic bronchoscopy in ICU

You may not qualify if:

  • Age\<18 years old or\>85 years old
  • Pregnant women
  • Patients undergoing emergency bronchoscopy examination
  • Patients who undergo bronchoscopy only to confirm the position of the artificial airway
  • Patients who are unable to wear EIT chest straps due to surgical incisions or closed drainage tubes in the chest
  • Patients who refuse to participate in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Shan Lyu, Master

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 25, 2023

Study Start

May 5, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations