Intubation ComplicationNCT04433884
Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery
A study testing Endotracheal intubation using a laryngoscope in people with Intubation Complication, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This study is being done to compare hemodynamic response upon endotracheal intubation using either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in patients undergoing elective coronary artery bypass grafting without anticipated difficult airway. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Endotracheal intubation using a laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jun 2020to 31 Jan 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35-65
- Elective Coronary Artery By Pass Grafting
- American Society Of Anesthesiologist III/IV
- Unanticipated difficult airway
- Mallampati I-II
Who cannot join
- Obese Body Mass Index > 35kg/m2
- Left Main Coronary Artery critical Disease
- Recent MI or unstable Angina
- Left heart failure/ Left ventricular ejection fraction<35%
- Upper lip bite test class III
- Thyromental distance <6.0 cm
Show all 13Show fewer
- Emergency surgery
- Anticipated difficult airway
- Respiratory Diseases
- Bleeding diathesis
- Neurological deficit
- Limited nuchal Range of motion
- Gastro Esophageal Reflux Disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology
Karachi, Sindh
Khalid Samad, MBBS,FCPS(Anesthesiology), 923343311603, khalid.samad@aku.edu
About this study
Official title: Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery - A Randomized Control Trial.
This study is being done to compare hemodynamic response upon endotracheal intubation using either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in patients undergoing elective coronary artery bypass grafting without anticipated difficult airway.
Read the detailed description
Patients will be premeditated with 7.5mg oral midazolam approximately 45-60 minutes prior to anesthesia. The standard monitoring of Electrocardiography for ST analysis and SPO2 will be monitored continuously. Capnography, tidal volume and airway pressure will also be monitored during anesthesia. Arterial line for invasive Blood Pressure monitoring, wide bore IV cannula will be placed before induction of anesthesia. Anesthesia technique will be standardized in both groups. After pre-oxygenation, anesthesia co-induction will be done with midazolam 0.02-0.05 mg/kg, propofol 0.5-1mg/kg and fentanyl 5mcg/kg. Cis-atracurium 0.15mg/kg will be used as muscle relaxant. Patient will be ventilated manually by using isoflurane (1% end tidal) in oxygen using facemask. ETT will be placed orally via direct laryngoscopy by MC and C-MAC blade 3 or 4 when a Train of Four would not be achieved. All intubation will be performed by senior experienced anesthetist having experience of at least 20 intubations using video laryngoscope.
After induction a central venous catheter will be placed for central venous pressure monitoring and a thermo dilution Swan Ganz catheter will be inserted if indicated.
Tracheal intubation will be performed using the standard Macintosh laryngoscope(MC) or C- MAC video laryngoscope (VL) (Karl Storz, Tuttlingen, Germany).
Hemodynamic changes, laryngoscopic view, the number of attempts, the time required for laryngoscopy and tracheal intubation, changes in rhythm, and intraoperative and post operative complications will be recorded. Heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP) and mean arterial pressure (MAP) along with peripheral oxygen saturation (SpO2), will be recorded before (T1) and after induction (T2), 1 minute after intubation (T3), 5 min (T4) and 10 min (T5)post intubation. End tidal carbon dioxide (EtCO2) will be recorded immediately after induction (T2), immediately after intubation 1 minute (T3), 5 min (T4) and 10 min (T5) post intubation. Measurements obtained after induction of anesthesia when the hemodynamics will be stable (post induction) will be considered as baseline measurements in the study.
Duration of laryngoscopy (DOL) is defined as the time from oral placement of the laryngoscope blade to obtaining the best glottic view. For the evaluation of glottic view during laryngoscopy, modified Cormack and Lehane Scoring System (m CL) and percentage of the glottis opening (POGO) score will be used. Duration of intubation (DOI) is defined as the time interval between oral placement of the ET to the attainment of tracing of 3 EtCO2 waveforms after intubation and initiation of mechanical ventilation. An attempt is defined as the time from introduction of laryngoscope into the oral cavity until its removal. Three attempts at intubation will be allowed for all groups. Failure to intubate will be defined as the inability to intubate after three attempts. An alternative technique will be used in cases of failure as per the discretion of anesthetist. In the case of multiple attempts, the duration of each attempt will be recorded. The duration of laryngoscopy and intubation (DOLI) is defined as the sum of all intubation attempts. The hemodynamic changes after intubation will be evaluated after successful intubation. After the study period, the anesthetic agents will be used as per the patient requirement. A number of unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded. The management of these complications will be done by primary anaesthesia team as per their feasibility and the costs of management of these complications will be covered under hospital insurance. Difficult intubation will be assessed by using Intubation Difficulty score (Table 1), Thyromental distance and Upper lip bite test.
Adverse effects of A number unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded.
- Conditions
- Intubation Complication
- Being tested
- Endotracheal intubation using a laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubation using a laryngoscopeDevice
Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded
| Study group | Role | What they receive |
|---|---|---|
| Conventional MAC Laryngoscope | Experimental | Patients in this group will undergo intubation using conventional macintosh laryngoscope Receives: Device: Endotracheal intubation using a laryngoscope |
| C-MAC Video laryngoscope | Experimental | Patients in this group will undergo intubation using video C-Mac laryngoscope Receives: Device: Endotracheal intubation using a laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure (in millimeters of Hg)
Hemodynamic response
Measured: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Changes in heart rate (beats per minute)
Hemodynamic response
Measured: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Secondary outcomes (2)
Arrhythmias
Presence of arrhythmias would be noted
Measured: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Perioperative myocardial ischemia
Presence of myocardial ischemia would be noted by ST segment changes
Measured: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start7 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehrish khan, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433884
- Sponsor's protocol ID
- 2020-3278-9046
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan S, Hameed M, Khan WR, Yousuf MS, Samad K. Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Conventional Macintosh Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jun 17;2026:2771364. doi: 10.1155/anrp/2771364. eCollection 2026.
PubMed 42327985
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery - A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04433884
- Acronym / sponsor ID
- 2020-3278-9046
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 16 Jun 2020 (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.
This study is being done to compare hemodynamic response upon endotracheal intubation using either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in patients undergoing elective coronary artery bypass grafting without anticipated difficult airway.
Detailed description
Patients will be premeditated with 7.5mg oral midazolam approximately 45-60 minutes prior to anesthesia. The standard monitoring of Electrocardiography for ST analysis and SPO2 will be monitored continuously. Capnography, tidal volume and airway pressure will also be monitored during anesthesia. Arterial line for invasive Blood Pressure monitoring, wide bore IV cannula will be placed before induction of anesthesia. Anesthesia technique will be standardized in both groups. After pre-oxygenation, anesthesia co-induction will be done with midazolam 0.02-0.05 mg/kg, propofol 0.5-1mg/kg and fentanyl 5mcg/kg. Cis-atracurium 0.15mg/kg will be used as muscle relaxant. Patient will be ventilated manually by using isoflurane (1% end tidal) in oxygen using facemask. ETT will be placed orally via direct laryngoscopy by MC and C-MAC blade 3 or 4 when a Train of Four would not be achieved. All intubation will be performed by senior experienced anesthetist having experience of at least 20 intubations using video laryngoscope.
After induction a central venous catheter will be placed for central venous pressure monitoring and a thermo dilution Swan Ganz catheter will be inserted if indicated.
Tracheal intubation will be performed using the standard Macintosh laryngoscope(MC) or C- MAC video laryngoscope (VL) (Karl Storz, Tuttlingen, Germany).
Hemodynamic changes, laryngoscopic view, the number of attempts, the time required for laryngoscopy and tracheal intubation, changes in rhythm, and intraoperative and post operative complications will be recorded. Heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP) and mean arterial pressure (MAP) along with peripheral oxygen saturation (SpO2), will be recorded before (T1) and after induction (T2), 1 minute after intubation (T3), 5 min (T4) and 10 min (T5)post intubation. End tidal carbon dioxide (EtCO2) will be recorded immediately after induction (T2), immediately after intubation 1 minute (T3), 5 min (T4) and 10 min (T5) post intubation. Measurements obtained after induction of anesthesia when the hemodynamics will be stable (post induction) will be considered as baseline measurements in the study.
Duration of laryngoscopy (DOL) is defined as the time from oral placement of the laryngoscope blade to obtaining the best glottic view. For the evaluation of glottic view during laryngoscopy, modified Cormack and Lehane Scoring System (m CL) and percentage of the glottis opening (POGO) score will be used. Duration of intubation (DOI) is defined as the time interval between oral placement of the ET to the attainment of tracing of 3 EtCO2 waveforms after intubation and initiation of mechanical ventilation. An attempt is defined as the time from introduction of laryngoscope into the oral cavity until its removal. Three attempts at intubation will be allowed for all groups. Failure to intubate will be defined as the inability to intubate after three attempts. An alternative technique will be used in cases of failure as per the discretion of anesthetist. In the case of multiple attempts, the duration of each attempt will be recorded. The duration of laryngoscopy and intubation (DOLI) is defined as the sum of all intubation attempts. The hemodynamic changes after intubation will be evaluated after successful intubation. After the study period, the anesthetic agents will be used as per the patient requirement. A number of unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded. The management of these complications will be done by primary anaesthesia team as per their feasibility and the costs of management of these complications will be covered under hospital insurance. Difficult intubation will be assessed by using Intubation Difficulty score (Table 1), Thyromental distance and Upper lip bite test.
Adverse effects of A number unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional MAC Laryngoscope | Experimental | Device: Endotracheal intubation using a laryngoscopePatients in this group will undergo intubation using conventional macintosh laryngoscope |
| C-MAC Video laryngoscope | Experimental | Device: Endotracheal intubation using a laryngoscopePatients in this group will undergo intubation using video C-Mac laryngoscope |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 35-65
- Elective Coronary Artery By Pass Grafting
- American Society Of Anesthesiologist III/IV
- Unanticipated difficult airway
- Mallampati I-II
Key exclusion criteria (13 listed)
- Obese Body Mass Index > 35kg/m2
- Left Main Coronary Artery critical Disease
- Recent MI or unstable Angina
- Left heart failure/ Left ventricular ejection fraction<35%
- Upper lip bite test class III
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 |
|---|---|---|
| Endotracheal intubation using a laryngoscopePatients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded | Device | C-MAC Video laryngoscope, Conventional MAC Laryngoscope |
Primary outcome
Changes in blood pressure (in millimeters of Hg)
Time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Hemodynamic response
Changes in heart rate (beats per minute)
Time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Hemodynamic response
2 secondary outcomes
Arrhythmias
Time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Perioperative myocardial ischemia
Time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 42327985Khan S, Hameed M, Khan WR, Yousuf MS, Samad K. Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Conventional Macintosh Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jun 17;2026:2771364. doi: 10.1155/anrp/2771364. eCollection 2026.
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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 Endotracheal intubation using a laryngoscope in people with Intubation Complication, 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 5 inclusion and 13 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 16 Jun 2020. 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 Sehrish Khan, MBBS (923347126366, sehrish.khan@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood pressure (in millimeters of Hg) (time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation). 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?
On the ClinicalTrials.gov record for NCT04433884, which also lists 1 linked publication.
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 16 Jun 2020.