LaryngoscopyNCT07510542
Comparison of Stress Response Evoked by Conventional Versus Videolaryngoscope
A study testing Endotracheal Intubation through a Video Laryngoscope (VL) and Endotracheal Intubation through a Direct Laryngoscope (DL) in people with Laryngoscopy and Stress Response, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
Impact of using video laryngoscopy versus direct laryngoscopy technique in terms of improved hemodynamics post intubation and time taken for intubation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngoscopy, Stress Response, Duration
- What is being tested?
- Endotracheal Intubation through a Video Laryngoscope (VL) and Endotracheal Intubation through a Direct Laryngoscope (DL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2026to 5 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I \& II
- Age 18-60 years.
- Preoperatively nonhypertensive and hemodynamically stable patients
- Patients scheduled for elective procedures not involving airway surgeries
- Patients with informed consent
- Mallampati score I and II
- Interincisor gap > 3 cms
- BMI less than 30 kg/m²
Who cannot join
- Patient refusal
- ASA III, IV \& V
- Hemodynamically unstable patients
- Patients with Hypertension and Ischemic Heart Disease (whether controlled or uncontrolled)
- Airway abnormalities, including congenital airway malformations \& maxillofacial abnormalities
- Head, neck or any facial traumas or history of prior head, neck or airway surgeries
- Emergency procedures
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
Syed M Abbas, FCPS, +923331318838, smabbas69@hotmail.com
About this study
Official title: Comparison of the Efficacy of Non-channelled Video Laryngoscopy Versus Direct Laryngoscopy in Terms of Stress Response and Intubation Time: a Single-blinded Randomized Controlled Trial
Impact of using video laryngoscopy versus direct laryngoscopy technique in terms of improved hemodynamics post intubation and time taken for intubation.
Read the detailed description
The research will be conducted as a single-blind study involving patients undergoing elective surgical processes that necessitate endotracheal intubation. Informed consent will be obtained from all patients. Participants will be randomly assigned through a computer-generated sequence number to either the DL (direct laryngoscopy) group or the VL (video laryngoscopy) group. Monitoring will include vital signs and measurements such as non-invasive blood pressure (NIBP), electrocardiography (ECG), and pulse oximetry (SpO2). Prior to the induction of anesthesia, each patient will undergo assessments including oxygen saturation, blood pressure, echocardiography, systolic, diastolic, and mean blood pressure, heart rate, and oxygen saturation. In addition to the stated observations, the same assessments will be done after one minute of induction, after three minutes of bag-mask ventilation, and one, three, and five minutes after intubation. The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. All subjects will be premedicated with Inj. midazolam 0.03 mg/kg. For all patients, the same general anesthesia protocol will be applied, with patients preoxygenated with 100% oxygen for three minutes prior to induction, which will be done with Inj. Nalbuphine 0.15 mg/kg and Inj. propofol 2 mg/kg I.V. After evaluating bag-mask ventilation, Inj. Atracurium at 0.6 mg/kg I.V. will be administered, and isoflurane at 1.2% (1 MAC) will be initiated. After three minutes of bag-mask ventilation, intubation will be performed using either direct laryngoscopy or a non-channelled video laryngoscope, and the time taken for laryngoscopy and intubation will be recorded. Based on the groups, one of the two methods will be utilized to insert the appropriate endotracheal tube. In Group A, endotracheal intubation will be conducted using an indirect non-channelled VL. In Group B, endotracheal intubation will be performed using DL. The placement of the tube will be verified through capnography and chest auscultation before it is secured in position.
Group A The intubation process will utilize the Besdata (BD-M7) Portable VL, which is an indirect laryngoscope without a channel. The investigator will use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.
Group B Endotracheal tube (ETT) insertion via DL with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group A.
Laryngoscopy in both groups will be conducted by an anesthetist with a minimum of five years of experience in anesthesia practice, ensuring the provision of high-quality care across both groups.
Data Analysis: The data collected will be analyzed via the SPSS software package v.26.0. Numerical variables will be presented as means (standard deviations) for normally distributed variables and as medians (IQRs) for non-normally distributed variables. For categorical variables (as frequencies), and group comparisons between numerical and categorical variables will be performed via the unpaired t-tests and the chi-square tests, respectively.
A p-value < 0.05 will be considered statistically significant.
- Conditions
- Laryngoscopy, Stress Response, Duration
- Being tested
- Endotracheal Intubation through a Video Laryngoscope (VL), Endotracheal Intubation through a Direct Laryngoscope (DL)
- Keywords
- Laryngoscopy, Stress response, Video laryngoscope
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal Intubation through a Video Laryngoscope (VL)Device
In this group, endotracheal intubation will be done through a video laryngoscope
Endotracheal Intubation through a Direct Laryngoscope (DL)Device
In this group, endotracheal intubation will be done through a direct laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngoscope (VL) | Experimental | The intubation process will utilize the Besdata (BD-M7) Portable Video Laryngoscope (VL), which is an indirect laryngoscope without a channel. We use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters. Receives: Device: Endotracheal Intubation through a Video Laryngoscope (VL) |
| Direct Laryngoscope (DL) | Active comparator | Endotracheal tube (ETT) insertion via Direct Laryngoscope (DL) with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group VL.
Laryngoscopy in both groups will be conducted by an anaesthetist with a minimum of five years of experience in anaesthesia practice, ensuring the provision of high-quality care across both groups. Receives: Device: Endotracheal Intubation through a Direct Laryngoscope (DL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be monitored through a 3-lead ECG monitor
Measured: Perioperative
Systolic Blood Pressure
Systolic Blood Pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
Measured: Perioperative
Diastolic Blood Pressure
Diastolic blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
Measured: Perioperative
Mean Blood Pressure
Mean blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
Measured: Perioperative
Secondary outcomes (1)
Duration of Laryngoscopy
The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. This involves measuring the interval from when the laryngoscope blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start5 Mar 2026
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngoscopyStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Syed M Abbas, Principal investigator, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510542
- Sponsor's protocol ID
- SIUT-ERC-2026/A-629
- Other IDs
- SIUT-ERC-2026/A-629
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Non-channelled Video Laryngoscopy Versus Direct Laryngoscopy in Terms of Stress Response and Intubation Time: a Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07510542
- Acronym / sponsor ID
- SIUT-ERC-2026/A-629
- Conditions
- Laryngoscopy, Stress Response, Duration
- Keywords
- Laryngoscopy, Stress response, Video laryngoscope
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 3 Apr 2026 (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.
Impact of using video laryngoscopy versus direct laryngoscopy technique in terms of improved hemodynamics post intubation and time taken for intubation.
Detailed description
The research will be conducted as a single-blind study involving patients undergoing elective surgical processes that necessitate endotracheal intubation. Informed consent will be obtained from all patients. Participants will be randomly assigned through a computer-generated sequence number to either the DL (direct laryngoscopy) group or the VL (video laryngoscopy) group. Monitoring will include vital signs and measurements such as non-invasive blood pressure (NIBP), electrocardiography (ECG), and pulse oximetry (SpO2). Prior to the induction of anesthesia, each patient will undergo assessments including oxygen saturation, blood pressure, echocardiography, systolic, diastolic, and mean blood pressure, heart rate, and oxygen saturation. In addition to the stated observations, the same assessments will be done after one minute of induction, after three minutes of bag-mask ventilation, and one, three, and five minutes after intubation. The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. All subjects will be premedicated with Inj. midazolam 0.03 mg/kg. For all patients, the same general anesthesia protocol will be applied, with patients preoxygenated with 100% oxygen for three minutes prior to induction, which will be done with Inj. Nalbuphine 0.15 mg/kg and Inj. propofol 2 mg/kg I.V. After evaluating bag-mask ventilation, Inj. Atracurium at 0.6 mg/kg I.V. will be administered, and isoflurane at 1.2% (1 MAC) will be initiated. After three minutes of bag-mask ventilation, intubation will be performed using either direct laryngoscopy or a non-channelled video laryngoscope, and the time taken for laryngoscopy and intubation will be recorded. Based on the groups, one of the two methods will be utilized to insert the appropriate endotracheal tube. In Group A, endotracheal intubation will be conducted using an indirect non-channelled VL. In Group B, endotracheal intubation will be performed using DL. The placement of the tube will be verified through capnography and chest auscultation before it is secured in position.
Group A The intubation process will utilize the Besdata (BD-M7) Portable VL, which is an indirect laryngoscope without a channel. The investigator will use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.
Group B Endotracheal tube (ETT) insertion via DL with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group A.
Laryngoscopy in both groups will be conducted by an anesthetist with a minimum of five years of experience in anesthesia practice, ensuring the provision of high-quality care across both groups.
Data Analysis: The data collected will be analyzed via the SPSS software package v.26.0. Numerical variables will be presented as means (standard deviations) for normally distributed variables and as medians (IQRs) for non-normally distributed variables. For categorical variables (as frequencies), and group comparisons between numerical and categorical variables will be performed via the unpaired t-tests and the chi-square tests, respectively.
A p-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscope (VL) | Experimental | Device: Endotracheal Intubation through a Video Laryngoscope (VL)The intubation process will utilize the Besdata (BD-M7) Portable Video Laryngoscope (VL), which is an indirect laryngoscope without a channel. We use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters. |
| Direct Laryngoscope (DL) | Active comparator | Device: Endotracheal Intubation through a Direct Laryngoscope (DL)Endotracheal tube (ETT) insertion via Direct Laryngoscope (DL) with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group VL. Laryngoscopy in both groups will be conducted by an anaesthetist with a minimum of five years of experience in anaesthesia practice, ensuring the provision of high-quality care across both groups. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- ASA I \& II
- Age 18-60 years.
- Preoperatively nonhypertensive and hemodynamically stable patients
- Patients scheduled for elective procedures not involving airway surgeries
- Patients with informed consent
Key exclusion criteria (8 listed)
- Patient refusal
- ASA III, IV \& V
- Hemodynamically unstable patients
- Patients with Hypertension and Ischemic Heart Disease (whether controlled or uncontrolled)
- Airway abnormalities, including congenital airway malformations \& maxillofacial abnormalities
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 through a Video Laryngoscope (VL)In this group, endotracheal intubation will be done through a video laryngoscope | Device | Video Laryngoscope (VL) |
| Endotracheal Intubation through a Direct Laryngoscope (DL)In this group, endotracheal intubation will be done through a direct laryngoscope | Device | Direct Laryngoscope (DL) |
Primary outcome
Heart rate
Time frame: Perioperative
Heart rate will be monitored through a 3-lead ECG monitor
Systolic Blood Pressure
Time frame: Perioperative
Systolic Blood Pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
Diastolic Blood Pressure
Time frame: Perioperative
Diastolic blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
Mean Blood Pressure
Time frame: Perioperative
Mean blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.
1 secondary outcome
Duration of Laryngoscopy
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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.
Syed M Abbas principal investigator
Sindh Institute of Urology and Transplantation
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 through a Video Laryngoscope (VL) and Endotracheal Intubation through a Direct Laryngoscope (DL) in people with Laryngoscopy and Stress Response, run by Sindh Institute of Urology and Transplantation 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed M Abbas, FCPS (02199215718 ext. 2193, smabbas1969@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Perioperative). The study lists 4 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 3 Apr 2026.