Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

NCT05805475 | Completed

• 1 other identifier: 2022-0072
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

Conditions

Mechanical Ventilation Complication; Pediatric Respiratory Diseases

Keywords

Pediatric Critical Care; Respiratory Mechanics; Tracheal Suctioning; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Weight of endotracheal suctioning

  Weight of endotracheal suctioning in milligrams

  Immediately after suctioning

Secondary Outcomes (6)

• Peak inspiratory pressure

  Baseline and 30 minutes

• Plateau pressure

  Baseline and 30 minutes

• Tidal volume

  Baseline and 30 minutes

• Dynamic compliance

  Baseline and 30 minutes

• Airway resistance

  Baseline and 30 minutes

Other Outcomes (3)

• Heart rate

  Baseline, immediately after suctioning and after 30 minutes

• Arterial blood pressure

  Baseline, immediately after suctioning and after 30 minutes

• Oxygen saturation

  Baseline, immediately after suctioning and after 30 minutes

Study Arms (2)

Endotracheal suctioning without expiratory pause

ACTIVE COMPARATOR

Conventional endotracheal suctioning in closed suction system

Other: Endotracheal suctioning without expiratory pause

Endotracheal suctioning with expiratory pause

EXPERIMENTAL

Endotracheal suctioning in closed suction system associated with expiratory pause maneuver

Other: Endotracheal suctioning with expiratory pause

Interventions

Endotracheal suctioning with expiratory pause OTHER

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Endotracheal suctioning with expiratory pause

Endotracheal suctioning without expiratory pause OTHER

Perform closed endotracheal suctioning without expiratory pause

Endotracheal suctioning without expiratory pause

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children at invasive mechanical ventilation for more than 24 hours;
• Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score \<10 and without a cough reflex);
• Endotracheal suctioning in a period \> 2h before the application of the technique.

You may not qualify if:

• Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
• Hemodynamic instability (hypotension refractory to treatment)
• Need of frequent endotracheal suctioning

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Study Officials

• Bruna Ziegler

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 10, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)