Hemodynamic ReboundNCT05133375
Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
A study testing Tracheal Intubation in people with Hemodynamic Rebound, run by CMH Jhelum at 1 site in Pakistan.
Trial summary
A total of 272 patients were randomly allocated into two groups, Patients in group A were treated with Macintosh laryngoscope and in groups B with McCoy laryngoscope was used for endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemodynamic Rebound
- What is being tested?
- Tracheal Intubation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 1 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both Male and Female
- Age between 18 to 70
- ASA I and II males and females.
- Malampatti I and II.
- Hemodynamically stable, no known ischemic heart disease and no history of hypertension.
- Nil per oral for at least 6 hours.
Who cannot join
- Non consenting patient.
- ASA III, IV or V patient.
- Malampati III or IV.
- Cervical instability
- Thyromental distance of less than 6cm, inter incisor distance of less than 3cm.
- Known case of hypertension and ischemic heart disease.
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- Pregnant female.
- Body mass index of more than 30.
- Patients of oropharyngeal surgery.
- Unable to Intubate in less than 1 minute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
A total of 272 patients were randomly allocated into two groups, Patients in group A were treated with Macintosh laryngoscope and in groups B with McCoy laryngoscope was used for endotracheal intubation. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Pro forma.
Read the detailed description
After taking approval from hospital ethical committee, 272 patients who reported to Operation Theatre of CMH, Jhelum were selected for the study. Informed consent was obtained and patient demographic information (name, age, contact) was recorded. Patients were randomly divided in two equal groups by using lottery method. GROUP A: Where Macintosh laryngoscope was used for endotracheal intubation. GROUP B: Where McCoy laryngoscope was used for endotracheal intubation.
Before reporting to Operation theatre a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Proforma.
- Conditions
- Hemodynamic Rebound
- Being tested
- Tracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal IntubationProcedure or surgery
Before reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Experimental | Macintosh laryngoscope was used for endotracheal intubation. Receives: Procedure: Tracheal Intubation |
| GROUP B | Experimental | McCoy laryngoscope was used for endotracheal intubation. Receives: Procedure: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the pulse of intubation with Macintosh and McCoy laryngoscope
To measure hemodynamic changes (i.e. pulse) of intubation with Macintosh and McCoy laryngoscope
Measured: After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope
To measure hemodynamic changes (i.e. systolic blood pressure) of intubation with Macintosh and McCoy
Measured: After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 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 posted24 Nov 2021
- Study start1 Apr 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic ReboundStudies 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
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Jhelum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Awais Qarni, CMH Jhelum
- Investigators
- Muhammad Awais Qarni, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133375
- Sponsor's protocol ID
- 11112021
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
- ClinicalTrials.gov ID
- NCT05133375
- Acronym / sponsor ID
- 11112021
- Conditions
- Hemodynamic Rebound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- CMH JhelumUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Nov 2021 (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.
A total of 272 patients were randomly allocated into two groups, Patients in group A were treated with Macintosh laryngoscope and in groups B with McCoy laryngoscope was used for endotracheal intubation. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Pro forma.
Detailed description
After taking approval from hospital ethical committee, 272 patients who reported to Operation Theatre of CMH, Jhelum were selected for the study. Informed consent was obtained and patient demographic information (name, age, contact) was recorded. Patients were randomly divided in two equal groups by using lottery method. GROUP A: Where Macintosh laryngoscope was used for endotracheal intubation. GROUP B: Where McCoy laryngoscope was used for endotracheal intubation.
Before reporting to Operation theatre a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Proforma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Procedure: Tracheal IntubationMacintosh laryngoscope was used for endotracheal intubation. |
| GROUP B | Experimental | Procedure: Tracheal IntubationMcCoy laryngoscope was used for endotracheal intubation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both Male and Female
- Age between 18 to 70
- ASA I and II males and females.
- Malampatti I and II.
- Hemodynamically stable, no known ischemic heart disease and no history of hypertension.
Key exclusion criteria (10 listed)
- Non consenting patient.
- ASA III, IV or V patient.
- Malampati III or IV.
- Cervical instability
- Thyromental distance of less than 6cm, inter incisor distance of less than 3cm.
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 |
|---|---|---|
| Tracheal IntubationBefore reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation. | Procedure or surgery | GROUP A, GROUP B |
Primary outcome
Effect on the pulse of intubation with Macintosh and McCoy laryngoscope
Time frame: After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
To measure hemodynamic changes (i.e. pulse) of intubation with Macintosh and McCoy laryngoscope
Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope
Time frame: After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation
To measure hemodynamic changes (i.e. systolic blood pressure) of intubation with Macintosh and McCoy
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 24 Nov 2021.
- Individual participant dataSharing planned: No. Overall results will be shared.
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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.
Muhammad Awais Qarni principal investigator
Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal Intubation in people with Hemodynamic Rebound, run by CMH Jhelum 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 6 inclusion and 10 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 24 Nov 2021. 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?
Effect on the pulse of intubation with Macintosh and McCoy laryngoscope (time frame: After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 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?
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 24 Nov 2021.