Thoracic DiseasesNCT05988736
Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.
A study testing MaCintosh Laryngoscope (DL) and McGrath Laryngoscope (VL) in people with Thoracic Diseases and Thoracic Neoplasms, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are, 1. Rate of successful intubation at first attempt and 2. Time for intubation required with each device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Diseases, Thoracic Neoplasms, Thoracic Empyema
- What is being tested?
- MaCintosh Laryngoscope (DL) and McGrath Laryngoscope (VL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2022to 31 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- American Society of Anaesthesiologists physical status (ASA) I, II, III
- Elective thoracic surgery patients, requiring one lung ventilation.
Who cannot join
- Patients requiring rapid sequence induction
- Patients with a structural problem in the airway on chest radiography
- History of difficult intubation
- Planned tracheostomy \ the presence of a tracheostomy
- Patients with a BMI >35 kg\m2. Who at risk of regurgitation\ Aspiration
- Anticipated Difficult Airway (Mallampati IV)
- Pre-existing sore throat or hoarseness, or recent respiratory infection (<15 days)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh
sadique Wadho, MBBS, +923322792932, sadique.ali@aku.edu
Khalid Samad, MBBS. FCPS, +923343311603, khalid.samad@aku.edu
About this study
Official title: Comparison Between McGrath and Macintosh Laryngoscopes for Double-lumen Tube Intubation in Patients Undergoing Thoracic Surgery, A Prospective Randomized Controlled Trial
The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,
- Rate of successful intubation at first attempt and
- Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.
- Conditions
- Thoracic Diseases, Thoracic Neoplasms, Thoracic Empyema
- Being tested
- MaCintosh Laryngoscope (DL), McGrath Laryngoscope (VL)
- Medical subject headings
- Thoracic Diseases, Thoracic Neoplasms, Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaCintosh Laryngoscope (DL)Device
A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.
McGrath Laryngoscope (VL)Device
A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: MaCintosh Laryngoscope (DL) |
| Group B | Active comparator | Not described Receives: Device: McGrath Laryngoscope (VL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for correct placement of the Double Lumen Tube (DLT).
Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.
Measured: During intervention time period
Successful Intubation at first attempt.
The number of times the laryngoscope will be inserted.
Measured: immediately after Intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Jun 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadique Ali, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988736
- Sponsor's protocol ID
- 2022-7215-21602
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between McGrath and Macintosh Laryngoscopes for Double-lumen Tube Intubation in Patients Undergoing Thoracic Surgery, A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05988736
- Acronym / sponsor ID
- 2022-7215-21602
- Conditions
- Thoracic Diseases, Thoracic Neoplasms, Thoracic Empyema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 2023 (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.
The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,
- Rate of successful intubation at first attempt and
- Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: MaCintosh Laryngoscope (DL) |
| Group B | Active comparator | Device: McGrath Laryngoscope (VL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- American Society of Anaesthesiologists physical status (ASA) I, II, III
- Elective thoracic surgery patients, requiring one lung ventilation.
Key exclusion criteria (7 listed)
- Patients requiring rapid sequence induction
- Patients with a structural problem in the airway on chest radiography
- History of difficult intubation
- Planned tracheostomy \ the presence of a tracheostomy
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 |
|---|---|---|
| MaCintosh Laryngoscope (DL)A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source. | Device | Group A |
| McGrath Laryngoscope (VL)A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis | Device | Group B |
Primary outcome
Time required for correct placement of the Double Lumen Tube (DLT).
Time frame: During intervention time period
Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.
Successful Intubation at first attempt.
Time frame: immediately after Intervention.
The number of times the laryngoscope will be inserted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MaCintosh Laryngoscope (DL) and McGrath Laryngoscope (VL) in people with Thoracic Diseases and Thoracic Neoplasms, run by Aga Khan University 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 7 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sadique Wadho, MBBS (+923322792932, sadique.ali@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for correct placement of the Double Lumen Tube (DLT). (time frame: During intervention time period). The study lists 2 primary outcomes in all. 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 14 Aug 2023.