Intubation ComplicationNCT06525779
Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope. A Randomized Control Trial
A study testing Use of macintosh laryngoscope and Use of mcGarth laryngoscope in people with Intubation Complication, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
For anatomical and physiological isolation of the lung, a specialized endotracheal tube known as the double lumen tube (DLT) is used. The introduction of DLT into anesthesia can be attributed to Carlen's who brought forth the concept in 1949. Since then the structure of DLT has continuously evolved. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Use of macintosh laryngoscope and Use of mcGarth laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2021to 25 Jul 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1, 2, 3 patients
- 18-60 years of age
- Patients undergoing surgery under general anesthesia requiring double lumen tube insertion (e.g. thoracic surgery, three stage esophagectomies)
Who cannot join
- Patient's refusal
- Patients with cervical spine instability/cervical myelopathy
- Patients requiring rapid sequence intubation
- Patients requiring additional intubation aids like bougie
- Patients having Wilson's Risk Score > 5 (refer to annexure)
- Patients with loose teeth
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital and Research Center
Lahore, Punjab Province, 54000
About this study
For anatomical and physiological isolation of the lung, a specialized endotracheal tube known as the double lumen tube (DLT) is used. The introduction of DLT into anesthesia can be attributed to Carlen's who brought forth the concept in 1949. Since then the structure of DLT has continuously evolved. Simplistically speaking; the double lumen tube is a co-axial tube i.e. it contains two tubes put together, the tube with the shorter length stays in the trachea whereas the tube with the longer length enters the right or left main bronchus. If the proximal or tracheal cuff is inflated, air entry is permitted into both lungs. However, if the distal or the bronchial cuff is inflated, ventilation is directed into either lung depending on which lumen has been clamped, at the proximal end of the tube. Conventionally the DLTs were made of red rubber and were reusable but now they have been replaced by disposable plastic tubes which make it easy to view any secretions or blood. Also, since the plastic makes for a thin wall it allows the lumen of the tube to be large enough to allow airflow with minimal resistance. Larger lumens also allow passage of suction catheters and fiber-optic bronchoscope which serves the purpose of confirming correct position of the double lumen tube after placement. Tracheal intubation with a DLT may be facilitated by maneuvers such as external laryngeal manipulation (ELM). It is a simple technique which has been used by anesthetists since many years to enable intubation. Various types of video-laryngoscopes (VL) have been found to perform a crucial part in patients with difficult airways McGrath video-laryngoscope - a portable machine - provides a better laryngeal view compared to Macintosh laryngoscopy, involving cases of intubation involving patients with normal or difficult airways. Though the use of VL for DLT placement has been reported, such studies have fallen short of producing the desired quality of evidence that is required to make a clear determination in favor of one method over the other. It is suggested that more work is needed on this in order to create a wider, more reliable data pool.
Read the detailed description
After approval from the hospital's institutional review board, a prospective clinical study was conducted at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH \& RC), Lahore, from January 25, 2021 to July 25, 2021. Data was collected from 60 patients that fulfilled the inclusion criteria. Features considered, included patients' demographic including age, gender, co-morbidities and American Society of Anesthesiologist physical status. In addition mallampati score, mouth opening and Wilson score of all patients was recorded as part of routine anesthesia airway assessment. Patients being taken for study were randomly assigned to either of the two groups of 30 each, that is all patients at odd numbers (1, 3, 7, 9 etc.) was allocated to Group 1 (McGrath laryngoscope) whereas all patient at even numbers (2, 6, 8, 10 etc.) was allocated to Group 2 (Macintosh laryngoscope). After explaining the procedure in detail and obtaining an informed consent in the presence of a witness, patients were transferred to the operating room. After standard induction of anesthesia, tracheal intubation using either of the two laryngoscopes depending on group allocation (McGrath laryngoscope or Macintosh laryngoscope) was performed by a designated anesthesia consultant experienced in the use of double-lumen tubes. The requirement of external laryngeal manipulation was recorded on a predesigned checklist.
- Conditions
- Intubation Complication
- Being tested
- Use of macintosh laryngoscope, Use of mcGarth laryngoscope
- Keywords
- Double Lumen Tube, External Laryngeal Manipulation, Macintosh, McGrath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of macintosh laryngoscopeDevice
The requirement of external laryngeal manipulation recorded in use of macintosh vs mcGrath laryngoscope in double lumen tube insertion
Use of mcGarth laryngoscopeDevice
Use of mcGarth laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Macintosh Laryngoscope Group | Active comparator | Patient undergoing intubation with direct laryngoscope using macintosh laryngoscope Receives: Device: Use of macintosh laryngoscope |
| McGrath Laryngoscope Group | Active comparator | Patient undergoing intubation with video laryngoscope using mcGrath laryngoscope Receives: Device: Use of mcGarth laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of External Laryngeal Manipulation
Requirement of External Laryngeal Manipulation
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start25 Jan 2021
- Primary completion25 Jul 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Rasheed, Shaukat Khanum Memorial Cancer Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525779
- Sponsor's protocol ID
- IRB-19-15
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: no plan yet
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06525779
- Acronym / sponsor ID
- IRB-19-15
- Conditions
- Intubation Complication
- Keywords
- Double Lumen Tube, External Laryngeal Manipulation, Macintosh, McGrath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 29 Jul 2024 (actual)
- 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.
For anatomical and physiological isolation of the lung, a specialized endotracheal tube known as the double lumen tube (DLT) is used. The introduction of DLT into anesthesia can be attributed to Carlen's who brought forth the concept in 1949. Since then the structure of DLT has continuously evolved. Simplistically speaking; the double lumen tube is a co-axial tube i.e. it contains two tubes put together, the tube with the shorter length stays in the trachea whereas the tube with the longer length enters the right or left main bronchus. If the proximal or tracheal cuff is inflated, air entry is permitted into both lungs. However, if the distal or the bronchial cuff is inflated, ventilation is directed into either lung depending on which lumen has been clamped, at the proximal end of the tube. Conventionally the DLTs were made of red rubber and were reusable but now they have been replaced by disposable plastic tubes which make it easy to view any secretions or blood. Also, since the plastic makes for a thin wall it allows the lumen of the tube to be large enough to allow airflow with minimal resistance. Larger lumens also allow passage of suction catheters and fiber-optic bronchoscope which serves the purpose of confirming correct position of the double lumen tube after placement. Tracheal intubation with a DLT may be facilitated by maneuvers such as external laryngeal manipulation (ELM). It is a simple technique which has been used by anesthetists since many years to enable intubation. Various types of video-laryngoscopes (VL) have been found to perform a crucial part in patients with difficult airways McGrath video-laryngoscope - a portable machine - provides a better laryngeal view compared to Macintosh laryngoscopy, involving cases of intubation involving patients with normal or difficult airways. Though the use of VL for DLT placement has been reported, such studies have fallen short of producing the desired quality of evidence that is required to make a clear determination in favor of one method over the other. It is suggested that more work is needed on this in order to create a wider, more reliable data pool.
Detailed description
After approval from the hospital's institutional review board, a prospective clinical study was conducted at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH \& RC), Lahore, from January 25, 2021 to July 25, 2021. Data was collected from 60 patients that fulfilled the inclusion criteria. Features considered, included patients' demographic including age, gender, co-morbidities and American Society of Anesthesiologist physical status. In addition mallampati score, mouth opening and Wilson score of all patients was recorded as part of routine anesthesia airway assessment. Patients being taken for study were randomly assigned to either of the two groups of 30 each, that is all patients at odd numbers (1, 3, 7, 9 etc.) was allocated to Group 1 (McGrath laryngoscope) whereas all patient at even numbers (2, 6, 8, 10 etc.) was allocated to Group 2 (Macintosh laryngoscope). After explaining the procedure in detail and obtaining an informed consent in the presence of a witness, patients were transferred to the operating room. After standard induction of anesthesia, tracheal intubation using either of the two laryngoscopes depending on group allocation (McGrath laryngoscope or Macintosh laryngoscope) was performed by a designated anesthesia consultant experienced in the use of double-lumen tubes. The requirement of external laryngeal manipulation was recorded on a predesigned checklist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh Laryngoscope Group | Active comparator | Device: Use of macintosh laryngoscopePatient undergoing intubation with direct laryngoscope using macintosh laryngoscope |
| McGrath Laryngoscope Group | Active comparator | Device: Use of mcGarth laryngoscopePatient undergoing intubation with video laryngoscope using mcGrath laryngoscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA 1, 2, 3 patients
- 18-60 years of age
- Patients undergoing surgery under general anesthesia requiring double lumen tube insertion (e.g. thoracic surgery, three stage esophagectomies)
Key exclusion criteria (6 listed)
- Patient's refusal
- Patients with cervical spine instability/cervical myelopathy
- Patients requiring rapid sequence intubation
- Patients requiring additional intubation aids like bougie
- Patients having Wilson's Risk Score > 5 (refer to annexure)
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 |
|---|---|---|
| Use of macintosh laryngoscopeThe requirement of external laryngeal manipulation recorded in use of macintosh vs mcGrath laryngoscope in double lumen tube insertion | Device | Macintosh Laryngoscope Group |
| Use of mcGarth laryngoscopeUse of mcGarth laryngoscope | Device | McGrath Laryngoscope Group |
Primary outcome
Requirement of External Laryngeal Manipulation
Time frame: 6 MONTHS
Requirement of External Laryngeal Manipulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Yes. no plan yet
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of macintosh laryngoscope and Use of mcGarth laryngoscope in people with Intubation Complication, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 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 29 Jul 2024. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Requirement of External Laryngeal Manipulation (time frame: 6 MONTHS). 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 Jul 2024.