Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients

Aspiration Clinical Trial

— AMYLASPI  

Official title:

Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients: a Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807884
• Other study ID #: AMYLASPI
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: July 10, 2017
• Start date: November 12, 2014
• Est. completion date: March 4, 2016

Study information

• Verified date: July 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.

Description:

• Study design : This is an open prospective, cross-over cohort study, including patients ventilated in one medical intensive care unit. Two procedures will be compared in two distinct, randomly decided cross-over consecutive periods

• Detailed description : Standard cares include tracheal suctions several times a day. They can induce a cough reflex in non paralysed patients leading to the mobilisation of the endotracheal tube and a consecutive raise in the risk of tracheal microaspiration. Thus drainage of subglottic secretion before tracheal suction is expected to reduce microaspiration. Subglottic secretion drainage could decrease the risk of Ventilator Associated Pneumonia even if it remains to be confirmed. However, no study assessed its efficiency in reducing tracheal microaspiration.

An optimization of the oropharyngeal suction procedure will include the use of a subglottic drainage in a specified order to realize a so called "optimized oral care". A comparison will be done with a routine oral care.

We will conduct a crossover study in which the patient's follow-up will last 2 days. Length of suction procedure and mouth care, volume of oral, subglottic and tracheal secretions and their qualitative appearance will be collected. The amylase enzymatic activity will be assessed in oropharyngeal, subglottic and tracheal samples.

• Registry procedure : All requested information will be recorded on case report forms and explanation will be reported for any missing data. False data will be clearly corrected, and signed by investigator or authorised person. For biochemical data (amylase enzymatic activity), results will be transmitted through excel software via a key and data will be integrated to the principal excel file on professional computer of the investigator.

Monitoring will be realised by the co-investigator in association with the clinical research associate.

• Quality factors. This clinical research associates will regularly check data to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry and a report will be report after each checking.

• Sample size assessment: Number of subjects : 24 patients. Six months should be necessary to include these patients.

• Statistical analysis : The sample size estimate assumed a median ratio of 8% and an estimated reduction from 8 to 2% with the optimized oral care. We determined that 12 patients per group would provide a power of 80%, with an α level of 5%.

Results will be expressed as means ± Standard Deviation. Continuous variables will be compared using the Student's t-test for matched paired series and categorical variables using the Chi 2 test. All p values and confidence intervals will be two-tailed. p<0.05 will be considered to be statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 4, 2016
• Est. primary completion date: March 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intubated with a subglottic secretion drainage device

• ventilated more than 48 hours

• patients yielding a significant tracheal suctioning volume (on a semi-qualitative evaluation: = ++ on a scale consisting of 0,+,++,+++)

Exclusion Criteria:

• paralysed patients

• patients with Ramsay 1, 2

• patients breathing spontaneously

• patients less than 18 years old

• patients in a moribund state

• contra-indication for suctioning procedure (risk of haemorrhage, bronchospasm, Acute Respiratory Distress Syndrome with P/F < 100, malformation or tracheal fistula)

• bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease

• patients necessitating a closed-suctioning device (prevention of respiratory multiresistant bacteria transmission, Acute Respiratory Distress Syndrome with P/F ratio < 100)

• pregnant women

Related Conditions & MeSH terms

• Aspiration
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Acquired Pneumonia

Intervention

Procedure:
• Optimized oral care
An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction

Other:
• Routine oral care
Oral suction followed by mouth care and tracheal suction without any subglottic suction

Locations

Country	Name	City	State
France	Hospital Pellegrin	Bordeaux	Gironde

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Teleflex

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tracheal to oropharyngeal ratio of amylase enzymatic activity	As a surrogate for microaspiration, the tracheal to oropharyngeal ratio of amylase enzymatic activity will be assessed after oral care. A mean of measures realized one day after optimized oral care will be compared to a mean of measure realized the other day after standard oral care as a cross over protocol.	Day 1 and Day 2
Secondary	volume of the tracheal, subglottic, and oral suctions	qualitative evaluation of volume of the tracheal, oral and when applicable subglottic suctions	three time a day, during 2 days
Secondary	length of each mouth care	Length in minutes of each mouth care, including tracheal, oral and when applicable subglottic, suctions	three time a day, during 2 days
Secondary	cost of the optimized oral suctioning compared with routine care	Mean cost of needed material and timed spented by nurses for each mouth care	At the end of the period of study (48hours) for each patient