Secretion Removal Above ETT CuffPhase 4NCT01386879

Evaluation of Above the Cuff Suctioning During General Anesthesia

A Phase 4 study testing methylene blue in people with Secretion Removal Above ETT Cuff, run by Thomas Jefferson University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Secretion Removal Above ETT Cuff
What is being tested?: methylene blue
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Oct 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Who cannot join

Short duration surgery (anticipated < 2 hours) or emergency (non-elective) surgery
ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
Pregnancy
History of allergic reaction to Methylene Blue medication
Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency

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History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (< 6 months prior to surgery).
Hypoxemia (hemoglobin oxygen saturation < 90% room air or on O2 at home or in hospital)
History of coagulopathy, IV heparin therapy, or coumadin therapy (INR > 2.5)

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Evaluation of Microaspiration and Efficacy of Above the Cuff Suctioning During General Anesthesia: A Comparison of Two Endotracheal Tubes With Suction Above Cuff With a Standard Endotracheal Tube

The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a significant reduction in the incidence of ventilator acquired pneumonia when a ETT with suction above the cuff is used to remove secretions that accumulate above the inflated cuff. This will be the first study to evaluate the efficacy of above the cuff suctioning during general anesthesia and surgery.

One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal or gynecological) requiring general anesthesia with an endotracheal tube and mechanical ventilation will be randomized into 3 groups to receive one of the following three endotracheal tubes:

Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT).
Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).
Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)

The first two groups will be compared to standard ETT (third group) regarding easy of tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the pharynx into the trachea and incidence of post-operative respiratory complications.

Conditions: Secretion Removal Above ETT Cuff
Being tested: methylene blue
Keywords: suction, aspiration, general anesthesia, intubation, endotracheal tube, respiratory complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

methylene blueDrug
Also called Urolene Blue
A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.

Study groups in NCT01386879
Study group	Role	What they receive
TaperGuard Evac ETT	Experimental	Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff Receives: Drug: methylene blue
Teleflex ISIS ETT	Experimental	Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff Receives: Drug: methylene blue
Standard ETT	Active comparator	Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube) Receives: Drug: methylene blue

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope.
Measured: 4 hours

Secondary outcomes (5)

Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the pH of the aspirate between two ETT with suction above the cuff port.
Measured: 4 hours
the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
Time to intubate trachea
Measured: 1 hour
Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT.
number of patients with mucosal injury and blood below the vocal cords
Measured: 4 hours
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap.
Measured: 4 hours
Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. The number of patients with a bacterial load of the aspirate between two ETT with suction above the cuff port was measured by gram stain of the aspirated secretions.
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Oct 2012

First posted1 Jul 2011 (estimated)
Study startJul 2011
Primary completionOct 2012
Study completionOct 2012

Why it stopped: The study was terminated because of slower than anticipated enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Secretion Removal Above ETT CuffStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01386879
Sponsor's protocol ID: 11D.48
Status last verified: May 2022
First submitted: 27 Jun 2011
Last updated: 8 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Microaspiration and Efficacy of Above the Cuff Suctioning During General Anesthesia: A Comparison of Two Endotracheal Tubes With Suction Above Cuff With a Standard Endotracheal Tube
ClinicalTrials.gov ID: NCT01386879
Acronym / sponsor ID: 11D.48
Conditions: Secretion Removal Above ETT Cuff
Keywords: suction, aspiration, general anesthesia, intubation, endotracheal tube, respiratory complications
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because of slower than anticipated enrollment
Enrolment: 50 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: Teleflex
Study start: Jul 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 1 Jul 2011 (estimated)
Results: Posted 8 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT).
Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).
Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
TaperGuard Evac ETT	Experimental	Drug: methylene blueTrachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff
Teleflex ISIS ETT	Experimental	Drug: methylene blueTrachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff
Standard ETT	Active comparator	Drug: methylene blueControl group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Key exclusion criteria (9 listed)

Short duration surgery (anticipated < 2 hours) or emergency (non-elective) surgery
ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
Pregnancy
History of allergic reaction to Methylene Blue medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
methylene blueAlso: Urolene BlueA dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.	Drug	Standard ETT, TaperGuard Evac ETT, Teleflex ISIS ETT

Primary outcome

Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
Time frame: 4 hours
The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope.

5 secondary outcomes

Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Time frame: 4 hours
the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
Time frame: 1 hour
Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT.
Time frame: 4 hours
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Time frame: 4 hours
Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Time frame: 4 hours

Results and safety

Results posted to the registry on 8 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TaperGuard Evac ETT	17	17
Teleflex ISIS ETT	17	17
Standard ETT	16	16

Primary outcome: Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery

Time frame: 4 hours. Number. Unit: number of participants with dye

Measure	TaperGuard Evac ETT n = 16	Teleflex ISIS ETT n = 17	Standard ETT n = 16
Value	0	0	2

Population analysed: the number of participants with dye in the distal trachea. One bronchoscopy recording was corrupted and not able to be evaluated in the GEvac group.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 h. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TaperGuard Evac ETT	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
Teleflex ISIS ETT	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
Standard ETT	0 of 16 (0%)	1 of 16 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boris Mraovic, MD principal investigator

Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methylene blue in people with Secretion Removal Above ETT Cuff, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01386879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.