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Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

NCT03940118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-05-08

No results posted yet for this study

Summary

Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning.

Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.

Conditions

  • Endotracheal Tube
  • Tracheostomy

Interventions

DEVICE

Catheter secretion suctioning

Catheter secretion suctioning with prior nebulization of hypertonic saline

COMBINATION_PRODUCT

Secretion suctioning + hypertonic saline

Catheter secretion suctioning with prior nebulization of hypertonic saline

DEVICE

Ins-exsufflation

Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

COMBINATION_PRODUCT

Ins-exsufflation + Hypertonic saline

Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Sponsors & Collaborators

  • Chiesi España

    collaborator UNKNOWN

  • Philips Respironics

    collaborator INDUSTRY

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Miguel Sanchez Garcia, MD, PhD · Hospital Clinico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940118 on ClinicalTrials.gov