Does Deflating the Tracheal Cuff Shorten Weaning Time?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier:
NCT00956540
First received: August 6, 2009
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to determine whether deflating the tracheal cuff in tracheostomized patients, during disconnections from ventilatory support along the weaning phase shortens the weaning time.


Condition Intervention Phase
Weaning
Tracheostomy
Procedure: Deflating tracheal cuff
Procedure: Deflating tracheal cuff 2
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Deflating the Tracheal Cuff During Ventilatory Disconnections on Weaning Time

Further study details as provided by Hospital Virgen de la Salud:

Primary Outcome Measures:
  • Weaning Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.


Secondary Outcome Measures:
  • Tracheobronchitis and Pneumonia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 195
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deflating
Deflating tracheal cuff (total air suction under negative pressure using a syringe) during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support. During ventilatory support the tracheal cuff remain pressurized (30 mmHg).
Procedure: Deflating tracheal cuff
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.
No Intervention: Not deflating
The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support
Experimental: Deflating 2
Deflating tracheal cuff during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.
Procedure: Deflating tracheal cuff 2
Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
No Intervention: Not deflating 2
The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.

Detailed Description:

Randomized controlled trial.

Study protocol: patients will be eligible for the study after fulfilling standard criteria for weaning initiation and stratified for risk of aspiration (drink test)into two categories:

  • Low/moderate risk patients (see later).
  • High risk patients (spontaneous aspiration of pharyngeal secretions), will be excluded from the study.

After this evaluation patients will be randomized (concealed allocation) stratifying with the tracheostomy indication.

Weaning and Decannulation Protocol: Attempts to discontinue mechanical ventilation (MV) will be initiated when the tracheostomized patients fulfill the criteria (recovery from the precipitating illness; respiratory criteria consisting of a PaO2/fraction of inspired oxygen ratio of >150 mm Hg with a positive end-expiratory pressure <8 cm H2O, and an arterial pH >7.32; and clinical criteria consisting of the absence of myocardial ischemia determined by ECG, no need for vasoactive drugs or dopamine ≤5 µg/kg/min, a heart rate <140 beats/min, haemoglobin concentration >8 g/dL, temperature <38°C, no need for sedative drugs, presence of respiratory stimulus and spontaneous cough deemed clinically appropriate. Patients will be screened daily for these criteria).

A clinical algorithm for progressive weaning from mechanical ventilation will be followed at the discretion of the attending physician. Patients will be weaned following one of two methods: progressive withdrawal of pressure support ventilation or T-tube trials. When patients tolerate spontaneous breathing for 12 hours on two consecutive days, they will remain connected to the T-tube continuously.

When the patient remain disconnected from mechanical ventilation for at least 24 hours, the investigators will assess his or her preparedness for decannulation. The investigators will perform the tracheostomy tube occlusion test to exclude tracheal obstruction to airflow.

At this point, the attending physician clinically will evaluate the patient's capacity to clear respiratory secretions mainly based on the frequency of the need for suctioning and the characteristics of respiratory secretions.

The nurse will suction subglottic secretions while deflating the cuff to avoid the risk of aspiration.

Criteria for decannulation: respiratory secretions management considered adequate (<2 aspiration every 8 hours) and low risk of aspiration.

End-points:

  • Weaning time: starting the day of first disconnection (lasting <30 minutes)and ending the day the patient is liberated from mechanical ventilation (patients will be considered weaned after 24 consecutive hours disconnected from mechanical ventilation).
  • Tracheobronchitis and pneumonia after randomization. Safety considerations: The main safety concern is the risk of aspiration. First all patients will be categorized in three steps using the drink test: low risk patients (normal drink test) with no other specific interventions; moderate risk (abnormal drink test) the risk of aspiration study will include a videolaryngoscopy; high risk patients will be excluded from the study. In all patients a high flow-humidified oxygen-air mixture system will be connected trough the external cannula.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: tracheostomized patients for any of the following reasons:

  • Prolonged time under mechanical ventilation (>21 days) or prolonged weaning.
  • Motor component of Glasgow Coma Score <6 points or inability to adequate manage the airway (>2 aspirations every 8 hours).

Exclusion Criteria:

  • High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomies indicated as a part of a surgical procedure involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
  • Death before starting weaning attempts.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956540

Locations
Spain
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Hospital Virgen de la Salud
Investigators
Study Chair: Gonzalo Hernandez, MD Hospital Virgen de la Salud
Principal Investigator: Maria del Mar Cruz, MD Hospital Virgen de la Salud
  More Information

No publications provided by Hospital Virgen de la Salud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gonzalo Hernandez Martinez, FEA Medicina Intensiva, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier: NCT00956540     History of Changes
Other Study ID Numbers: 29/06/09-54
Study First Received: August 6, 2009
Results First Received: July 1, 2011
Last Updated: August 19, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Virgen de la Salud:
Tracheostomy
decannulation
weaning
Tracheostomy Weaning

ClinicalTrials.gov processed this record on September 18, 2014