Pulmonary ComplicationNCT06391333
Supraglottic Airway vs Tracheal Intubation on PPCs Among High-risk Geriatric Patients
A study testing laryngeal mask airway and endotracheal tube in people with Pulmonary Complication, run by RenJi Hospital.
Trial summary
Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pulmonary Complication
- What is being tested?
- laryngeal mask airway and endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,210 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2024to 15 Jun 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score > 44 will be included
Who cannot join
- Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.
About this study
Official title: Comparison of Supraglottic Airway and Tracheal Intubation on Postoperative Pulmonary Complications Among High-risk Geriatric Patients
Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.
- Conditions
- Pulmonary Complication
- Being tested
- laryngeal mask airway and endotracheal tube
- Keywords
- Supraglottic airway, Tracheal intubation, Postoperative pulmonary complications, Geriatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal mask airway and endotracheal tubeDevice
The two most commonly used devices for mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| laryngeal mask airway | Active comparator | In this group, patients use a laryngeal mask airway for intraoperative mechanical ventilation. Receives: Device: laryngeal mask airway and endotracheal tube |
| endotracheal intubation | Placebo comparator | In this group, patients use a endotracheal tube for intraoperative mechanical ventilation. Receives: Device: laryngeal mask airway and endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPC
The primary outcome is the incidence of a collapsed composite of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Dr Wang's work published on Anesthesiology, 2022 (PMID: 35226725).
Measured: 7 days after surgery
Secondary outcomes (3)
extrapulmonary complications
extrapulmonary complications according to regular medical reports
Measured: 7 days after surgery
severity of PPC
Clavien Dindo criteria
Measured: 7 days after surgery
diagnosis of PPC
Postoperative pulmonary complications are defined by respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia (Diagnosed according to utcome is the incidence of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Anesthesiology, 2022 (PMID: 35226725).
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start5 May 2024 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 2,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391333
- Sponsor's protocol ID
- POLMA2
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Supraglottic Airway and Tracheal Intubation on Postoperative Pulmonary Complications Among High-risk Geriatric Patients
- ClinicalTrials.gov ID
- NCT06391333
- Acronym / sponsor ID
- POLMA2
- Conditions
- Pulmonary Complication
- Keywords
- Supraglottic airway, Tracheal intubation, Postoperative pulmonary complications, Geriatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,210 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 5 May 2024 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 30 Apr 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.
Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laryngeal mask airway | Active comparator | Device: laryngeal mask airway and endotracheal tubeIn this group, patients use a laryngeal mask airway for intraoperative mechanical ventilation. |
| endotracheal intubation | Placebo comparator | Device: laryngeal mask airway and endotracheal tubeIn this group, patients use a endotracheal tube for intraoperative mechanical ventilation. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score > 44 will be included
Key exclusion criteria (1 listed)
- Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.
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 |
|---|---|---|
| laryngeal mask airway and endotracheal tubeThe two most commonly used devices for mechanical ventilation. | Device | endotracheal intubation, laryngeal mask airway |
Primary outcome
PPC
Time frame: 7 days after surgery
The primary outcome is the incidence of a collapsed composite of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Dr Wang's work published on Anesthesiology, 2022 (PMID: 35226725).
3 secondary outcomes
extrapulmonary complications
Time frame: 7 days after surgery
severity of PPC
Time frame: 7 days after surgery
diagnosis of PPC
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal mask airway and endotracheal tube in people with Pulmonary Complication, run by RenJi Hospital.
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 1 inclusion and 1 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
PPC (time frame: 7 days after surgery). 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 30 Apr 2024.