NCT03256214

Brief Summary

Seventy-one patients in intensive care were randomized for initial treatment with open suction systems or closed suction systems in a cross-over design. Pulmonary and cardiovascular physiology was assessed immediately before and after three 10-second aspirations per suction. Were analyzed the effect of each suction system on physiologic parameters while adjusting for their respective values prior to suction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

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

February 2, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

July 18, 2017

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Improvements in Pulmonary parameters when comparing closed and open suction systems.

    Assessment of Peak Pressure (cmH20) in both closed and open suction systems.

    1 day

  • Improvements in Cardiovascular parameters when comparing Closed and open suction systems.

    Assessment of Blood Pressure (mmHg) in both closed and open suction systems.

    1 day

Study Arms (2)

Closed suction system

EXPERIMENTAL

Patients in mechanical ventilation were aspirated with closed suction system.

Procedure: Closed suction system

Open suction system

ACTIVE COMPARATOR

Patients in mechanical ventilation were aspirated with open suction system.

Procedure: Open suction system

Interventions

In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.

Closed suction system

In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.

Open suction system

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 years old;
  • intubated with a 7.5mm endotracheal tube;
  • mechanically ventilated.

You may not qualify if:

  • upper gastrointestinal bleeding;
  • hemodynamic instability;
  • airway bleeding;
  • previous lung diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Raimundo RD, Sato MA, da Silva TD, de Abreu LC, Valenti VE, Riggs DW, Perrow Carll A. Open and Closed Endotracheal Suction Systems Divergently Affect Pulmonary Function in Mechanically Ventilated Subjects. Respir Care. 2021 May;66(5):785-792. doi: 10.4187/respcare.08511. Epub 2021 Mar 9.

Study Officials

  • Rodrigo D Raimundo, Ph.D.

    Faculdade de Medicina do ABC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

July 18, 2017

First Posted

August 21, 2017

Study Start

February 2, 2015

Primary Completion

July 15, 2016

Study Completion

April 17, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08