Difficult Intubation in ICUNCT01816217
Difficult Intubation in Intensive Care
A study testing Intubation with The McGrath Mac videolaryngoscope in people with Difficult Intubation in ICU and Strictly More Than Two Laryngoscopies, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation in ICU, Strictly More Than Two Laryngoscopies, Cormack Grade Three/Four
- What is being tested?
- Intubation with The McGrath Mac videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient informed,
- Affiliated or benefit from a disease insurance regimen
- Available for a 28 days follow-up
- Men and women aged aged from at least 18 years
- Indication of intubation in ICU
Who cannot join
- Protected patient
- Opposition for study participation
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
About this study
Official title: Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study
Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4 rates in a prospective interventional study.The present study was conducted to test the hypothesis that the implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.
Read the detailed description
We planned to evaluate in a prospective before-after study performed in a single 16-beds medical-surgical ICU in a teaching hospital that an implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.During the two periods of the study (non-interventional vs interventional), we planned to evaluate 280 intubations. In the non-interventional phase, all intubations will be performed as the standard of care of the unit using the standard Macintosh laryngoscope for intubation procedure. For this period, 140 intubations will be evaluated and will be considered as a "control" group. After an inter-phase of training on manikin of 6 weeks with the new McGrath mac videolaryngoscope, the "interventional phase will started in aim to include 140 intubations with the McGrath Mac videolaryngoscope.
An intermediate analysis was planned after 70 intubations with McGrath mac videolaryngoscope to assess safety (severe life-threatening complications) and difficult intubation rate and/or Cormack 3-4.Taking into account this intermediate analysis, the number of subjects needed was of 280.
An intubation will be defined as difficult in case of more than two laryngoscopies.
The MACOCHA score and the usual risks factors associated with difficult intubation in operative rooms will be assessed: past difficult intubation, Mallampati score, thyromental distance, mouth opening, neck circumference, upper lip bite test, neck extension, sleep apnea, facial disease.
The following parameters will be recorded: admission diagnosis, age, sex, body mass index, indication for intubation, comorbidities, hour of intubation, SAPS (Simplified Acute Physiologic Score) II score, SOFA (Sequential Organ Failure Assessment) score, skill level of operator,, number of operators, medications used and corresponding doses, equipment used, number of attempts and airway management techniques, head and body position, use of a cricoid pressure.
The complications during intubation will be evaluated:
- respiratory (aspiration, esophageal intubation, saturation less than 80%),
- hemodynamic (systolic arterial pressure less than 65mmHg, high cardiac frequency (more than 150 beats/min) or low cardiac frequency (less than 50 beats/min), arythmias, cardiac arrest),
- neurologic (agitation),
- local (dental injury, airway trauma),
- death.
The complication in the hour following the intubation will be also assessed:
- respiratory: major desaturation (saturation less than 80%, pneumothorax, persistant hypoxia with a saturation less than 80%,
- hemodynamic (persistent hypotension: systolic arterial pressure less than 90mmHg in spite of vascular loading of 500mL of cristalloid solution or 250ml of colloid solution, rythm trouble, cardiac arrest, introduction or increase of vasopressors),
- neurologic (agitation),
- death. Finally, a follow up of 28 days will be done (patient alive at 28 days, or date of death).
- Conditions
- Difficult Intubation in ICU, Strictly More Than Two Laryngoscopies, Cormack Grade Three/Four
- Being tested
- Intubation with The McGrath Mac videolaryngoscope
- Keywords
- Difficult intubation, Complications, Intensive care units, Videolaryngoscope, Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with The McGrath Mac videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Intubated patient | Experimental | Adult intubated in Intensive Care Unit (ICU) with The McGrath Mac videolaryngoscope (intervention described) Receives: Device: Intubation with The McGrath Mac videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of difficult intubation or/and Cormack 3-4
Measured: during the intubation
Secondary outcomes (6)
The severe life-threatening complications related to intubation in ICU
Severe life-threatening complications are defined as death, cardiac arrest, severe cardiovascular collapse, defined as systolic blood pressure<65 mm Hg recorded at least one time and/or <90 mm Hg that lasted 30min despite 500-1,000 ml of fluid loading (crystalloids/or colloids solutions) and/or requiring introduction of vasoactive support, or severe hypoxemia (decrease in SpO2 below 80% during attempts).
Measured: until 28 days after intubation
The moderate complications related to intubation in ICU
Mild to moderate complications are defined as esophageal intubation, aspiration of gastric contents (migration of stomach contents into the lung, supraventricular and/or ventricular arrhythmia (without pulseless rhythm) that require therapy, dangerous agitation (Richmond Agitation-Sedation Scale (RASS) score above 3) or dental injury.
Measured: until 28 days after intubation
The success rate of intubation on the first attempt
An intubation attempt is defined as the introduction of the endotracheal tube past the patient's teeth or as a laryngoscopic failure without the introduction of the endotracheal tube. A laryngoscopic blade readjustment counts as a single attempt.
Measured: during the intubation
The number of intubation attempts
Measured: during the intubation
The glottic view
Measured: during the intubation
The success rate
Measured: during the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: The interim analysis has shown a significative difference between the two groups of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Intubation in ICUStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir SJ JABER, MD, PhD, Principal investigator, Anesthesiology and Critical Care Medicine of CHU of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816217
- Sponsor's protocol ID
- UF 8977
- Status last verified
- Aug 2013
- First submitted
- 13 Mar 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT01816217
- Acronym / sponsor ID
- UF 8977
- Conditions
- Difficult Intubation in ICU, Strictly More Than Two Laryngoscopies, Cormack Grade Three/Four
- Keywords
- Difficult intubation, Complications, Intensive care units, Videolaryngoscope, Laryngoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The interim analysis has shown a significative difference between the two groups of patients.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4 rates in a prospective interventional study.The present study was conducted to test the hypothesis that the implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.
Detailed description
We planned to evaluate in a prospective before-after study performed in a single 16-beds medical-surgical ICU in a teaching hospital that an implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.During the two periods of the study (non-interventional vs interventional), we planned to evaluate 280 intubations. In the non-interventional phase, all intubations will be performed as the standard of care of the unit using the standard Macintosh laryngoscope for intubation procedure. For this period, 140 intubations will be evaluated and will be considered as a "control" group. After an inter-phase of training on manikin of 6 weeks with the new McGrath mac videolaryngoscope, the "interventional phase will started in aim to include 140 intubations with the McGrath Mac videolaryngoscope.
An intermediate analysis was planned after 70 intubations with McGrath mac videolaryngoscope to assess safety (severe life-threatening complications) and difficult intubation rate and/or Cormack 3-4.Taking into account this intermediate analysis, the number of subjects needed was of 280.
An intubation will be defined as difficult in case of more than two laryngoscopies.
The MACOCHA score and the usual risks factors associated with difficult intubation in operative rooms will be assessed: past difficult intubation, Mallampati score, thyromental distance, mouth opening, neck circumference, upper lip bite test, neck extension, sleep apnea, facial disease.
The following parameters will be recorded: admission diagnosis, age, sex, body mass index, indication for intubation, comorbidities, hour of intubation, SAPS (Simplified Acute Physiologic Score) II score, SOFA (Sequential Organ Failure Assessment) score, skill level of operator,, number of operators, medications used and corresponding doses, equipment used, number of attempts and airway management techniques, head and body position, use of a cricoid pressure.
The complications during intubation will be evaluated:
- respiratory (aspiration, esophageal intubation, saturation less than 80%),
- hemodynamic (systolic arterial pressure less than 65mmHg, high cardiac frequency (more than 150 beats/min) or low cardiac frequency (less than 50 beats/min), arythmias, cardiac arrest),
- neurologic (agitation),
- local (dental injury, airway trauma),
- death.
The complication in the hour following the intubation will be also assessed:
- respiratory: major desaturation (saturation less than 80%, pneumothorax, persistant hypoxia with a saturation less than 80%,
- hemodynamic (persistent hypotension: systolic arterial pressure less than 90mmHg in spite of vascular loading of 500mL of cristalloid solution or 250ml of colloid solution, rythm trouble, cardiac arrest, introduction or increase of vasopressors),
- neurologic (agitation),
- death. Finally, a follow up of 28 days will be done (patient alive at 28 days, or date of death).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated patient | Experimental | Device: Intubation with The McGrath Mac videolaryngoscopeAdult intubated in Intensive Care Unit (ICU) with The McGrath Mac videolaryngoscope (intervention described) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient informed,
- Affiliated or benefit from a disease insurance regimen
- Available for a 28 days follow-up
- Men and women aged aged from at least 18 years
- Indication of intubation in ICU
Key exclusion criteria (2 listed)
- Protected patient
- Opposition for study participation
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 |
|---|---|---|
| Intubation with The McGrath Mac videolaryngoscope | Device | Intubated patient |
Primary outcome
The incidence of difficult intubation or/and Cormack 3-4
Time frame: during the intubation
6 secondary outcomes
The severe life-threatening complications related to intubation in ICU
Time frame: until 28 days after intubation
The moderate complications related to intubation in ICU
Time frame: until 28 days after intubation
The success rate of intubation on the first attempt
Time frame: during the intubation
The number of intubation attempts
Time frame: during the intubation
The glottic view
Time frame: during the intubation
The success rate
Time frame: during the intubation
Results and safety
The study was stopped early (reason given: The interim analysis has shown a significative difference between the two groups of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
Related trials for Difficult Intubation in ICU
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Not yet recruitingObservational study
Comparison Between C-mac,Pentax Video Laryngoscopes and Machintosh Laryngoscope
Intubation; Difficult or Failed
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.
Samir SJ JABER, MD, PhD principal investigator
Anesthesiology and Critical Care Medicine of CHU of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation with The McGrath Mac videolaryngoscope in people with Difficult Intubation in ICU and Strictly More Than Two Laryngoscopies, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 2 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 29 Aug 2013. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: The interim analysis has shown a significative difference between the two groups of patients.). Results are not available in the source record.
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?
The incidence of difficult intubation or/and Cormack 3-4 (time frame: during the intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2013.