Intubation; DifficultNCT01749631

Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

An observational study of Intubation; Difficult, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Intubation; Difficult
Type of treatment: Injection or infusion
How many people: 97 participants
Where: No sites listed yet
Study dates: Dec 2012to Feb 2015
Phase: Observational
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hospitals with operation theaters

Who may be able to join

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV
2. Patients with at least one of the below criteria:
Anatomic
micrognathia - small mandible
macroglossia - large tongue
short or fixed neck

Show all 25Show fewer

anterior vocal cords
Trauma - neck or face
Burns - airway edema
Infections - edema
Retropharyngeal abscess
Submandibular abscess
epiglottitis
laryngotracheobronchitis (croup)
Neoplasms; e.g., laryngeal tumors
Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
Diabetes mellitus
Waxy skin - palm test
Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
airway closure in supine position
Morbid obesity (body mass index [BMI] >35)
Airway edema
Laryngospasm
Edentulous patients - indent cheeks.
3. Patients willing to sign informed consent

Who cannot join

Patients with present use of opioids and/or narcotic dependent.
Patients with known sensitivity to sevoflurane or to other halogenated agents.
Patients with known or suspected genetic susceptibility to malignant hyperthermia.
Alcohol addictive patients.
Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
Patient is a pregnant or breastfeeding female

About this study

Official title: A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

Read the detailed description

This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.

Conditions: Intubation; Difficult
Keywords: Patients suspected to have difficult intubation, Intratracheal intubation, Difficult to intubate

What participants receive

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

Study groups in NCT01749631
Study group	Role	What they receive
Difficult to Intubate (DTI) Participants		Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

What is being measured

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

Percentage of Participants With Successful Intubation (Clinical Success)
Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.
Measured: Start of intubation to completion of intubation (up to 15 minutes)

Secondary outcomes (6)

Mean Duration of Induction (in Seconds)
The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.
Measured: From start of induction up to 15 minutes
Percentage of Participants With Mallampati Score III and IV
Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.
Measured: Screening
Mean Duration of Intubation Procedure (in Minutes)
The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).
Measured: Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure
The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.
Measured: Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane
The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.
Measured: From start of induction to completion of intubation (up to 30 minutes)
Mean Number of Intubation Attempts
Measured: Start of intubation to completion of intubation (up to 15 minutes)

Timeline

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

Dec 2012Feb 2015

First posted17 Dec 2012 (estimated)
Study startDec 2012
Primary completionFeb 2015
Study completionFeb 2015

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 Intubation; DifficultStudies of the same condition, open and under way.
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: Observational
Time perspective: Prospective
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01749631
Sponsor's protocol ID: P13-805
Status last verified: Feb 2016
First submitted: 12 Dec 2012
Last updated: 1 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
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Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
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Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation

All Intubation; Difficult trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
ClinicalTrials.gov ID: NCT01749631
Acronym / sponsor ID: P13-805
Conditions: Intubation; Difficult
Keywords: Patients suspected to have difficult intubation, Intratracheal intubation, Difficult to intubate
Study type: Observational
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Posted 1 Mar 2016

Clinical summary

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

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Difficult to Intubate (DTI) Participants	–	–Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hospitals with operation theaters

Key inclusion criteria (25 listed)

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV
Anatomic
Trauma - neck or face
Burns - airway edema
Infections - edema

Key exclusion criteria (6 listed)

Patients with present use of opioids and/or narcotic dependent.
Patients with known sensitivity to sevoflurane or to other halogenated agents.
Patients with known or suspected genetic susceptibility to malignant hyperthermia.
Alcohol addictive patients.
Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)

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

Primary outcome

Percentage of Participants With Successful Intubation (Clinical Success)
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.

6 secondary outcomes

Mean Duration of Induction (in Seconds)
Time frame: From start of induction up to 15 minutes
Percentage of Participants With Mallampati Score III and IV
Time frame: Screening
Mean Duration of Intubation Procedure (in Minutes)
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane
Time frame: From start of induction to completion of intubation (up to 30 minutes)
Mean Number of Intubation Attempts
Time frame: Start of intubation to completion of intubation (up to 15 minutes)

Results and safety

Results posted to the registry on 1 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Difficult to Intubate (DTI) Participants	97	97

Primary outcome: Percentage of Participants With Successful Intubation (Clinical Success)

Time frame: Start of intubation to completion of intubation (up to 15 minutes). Number. Unit: percentage of participants

Measure	Difficult to Intubate (DTI) Participants n = 96
Success	96.9
Failure	3.1

Population analysed: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were collected from the time of study drug administration to end of intubation procedure (up to 30 minutes); SAEs were also collected from the time that informed consent was obtained until 30 days after last dose of study drug (30 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Difficult to Intubate (DTI) Participants	0 of 97 (0%)	2 of 97 (2.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Intubation; Difficult

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation

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.

Amr Alaa study director

AbbVie Egypt

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation; Difficult, run by AbbVie (prior sponsor, Abbott).

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 25 inclusion and 6 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: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2016). 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?

Percentage of Participants With Successful Intubation (Clinical Success) (time frame: Start of intubation to completion of intubation (up to 15 minutes)). 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 NCT01749631.

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 1 Mar 2016.