oPAP Should be > 25mmHg in Right Heart Catheterization at RestPulmonaryHTNCT05565911
Postoperative Morbidity / Mortality Rates of Patients With Pulmonary Hypertension
An observational study of oPAP Should be > 25mmHg in Right Heart Catheterization at Rest and There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary hypertension (PHT) is an oPAP ≥25 mmHg as assessed by right heart catheterization at rest. It is divided into 5 groups according to its etiology and mechanism. The first group is patients with pulmonary arterial hypertension due to various reasons (drugs, connective tissue diseases, etc.). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- oPAP Should be > 25mmHg in Right Heart Catheterization at Rest, There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Oct 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Araştırma kapsamında pulmoner hipertansiyonu olan hastaların geçirecekleri cerrahilerde kendi hasta popülasyonlarına özel ne gibi risk faktörlerine sahip oldukları, tedavi olan ve olmayanlarda postoperatif komplikasyon gelişme sıklığının araştırılması planlanmaktadır
Who may be able to join
- • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB> 25mmHg olan hastalar,
- Non-obstetrik ve non-kardiyak cerrahi geçirecek hastalar
Who cannot join
- • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB< 25mmHg olan hastalar,
- Obstetrik veya kardiyak cerrahi geçirecek hastalar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Postoperative Morbidity / Mortality Rates of Patients With Pulmonary Hypertension With Risk Factors
Pulmonary hypertension (PHT) is an oPAP ≥25 mmHg as assessed by right heart catheterization at rest. It is divided into 5 groups according to its etiology and mechanism. The first group is patients with pulmonary arterial hypertension due to various reasons (drugs, connective tissue diseases, etc.). Group 2 is classified as left heart failure, group 3 is due to chronic lung disease and hypoxemia, group 4 is due to pulmonary arterial obstruction (most commonly CTEPH), and group 5 is patients with pulmonary hypertension due to multifactorial unspecified causes.
In the pathophysiology, pulmonary hypertension occurs when the balance is disturbed by endothelial dysfunction, decrease in vasodilator mediators (NO, prostacyclin) and increase in vasoconstrictor mediators (endothelin-1, serotonin, thromboxan) in the vascular bed.
Read more
Perioperatively, patients with WHO functional classification >2, right ventricular hypertrophy, obese, chronic renal failure, previous PTE, COPD, diabetes mellitus are more prone to complications related to pulmonary hypertension. Although factors such as emergency surgery, intraoperative vasopressor use, delayed intubation, acidosis, and hyperthermia pave the way for postoperative pulmonary complications, attention should be paid to mortality and morbidity since they are also preventable factors.
Postoperatively, as a result of the supine position triggering bronchospasm with secretions, acute lung injury in addition to the existing comorbidity occurs. With the increase in respiratory workload, acute respiratory failure develops with symptoms such as hypoxemia and hypercarbia. Residual anesthesia, increased pain or prolonged mechanical ventilation time also decrease functional residual capacity, increasing the possibility of atelectasis development.
With the records we kept in our study, we aimed to show which complications the patients with pulmonary hypertension faced after their surgeries due to their underlying diseases and References ESC/ERC Guidelines Eurepean Heart Journal 2016; 37:67-119 Aguirre MA, et al. Advances in Anesthesia 2018;36: 201-30
Read the detailed description
Our study will be carried out by recording the patients with PHT who underwent non-cardiac and non-obstetric surgeries at Başkent University Ankara Hospital between 11/10/2021 and 11/10/2023. It was planned to select the patients participating in our study on a voluntary basis and to include only the patients who agreed to participate in the study. Informed consent will be obtained by informing the patients before the application.
Both patient groups will be evaluated in the anesthesia polyclinic in the preoperative period. Routine blood tests will be done. It was planned as a cohort study. Depending on the surgery type of the patients, GA or RA will be applied as appropriate. The drugs in the standard anesthesia method will be administered to the patients. Standard monitoring and, if necessary, other invasive monitoring methods will be applied. Echocardiography evaluations, pulmonary function tests will be planned, and control evaluations will be requested at the 3rd, 6th and 1st postoperative months.
By the team in the postoperative recovery unit, hypoventilation (falling below breath per minute), apnea (episodes longer than 10 seconds), hypoxemia (SpO2<90, nasal O2 or Room Air), tachypnea, dyspnea, arrhythmia, chest pain, tachycardia, hypotension 30 minutes in terms of symptoms such as hypertension, laryngospasm, bronchospasm, subcostal retraction. They will be followed throughout. They will be evaluated in terms of analgesia control with Numeric Pain Score.
It will be evaluated in terms of postoperative pulmonary complications (tracheal reintubation) in the recovery unit and afterwards, extubation failure, pulmonary edema, and pneumothorax at the end of the case, and records will be kept.
- Conditions
- oPAP Should be > 25mmHg in Right Heart Catheterization at Rest, There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery
- Being tested
- no intervention
- Keywords
- pulmonary hypertension, hemodinamic monitorization
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is an observational study, there is no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of postoperative morbidity/mortality
In this study, we investigated how the risk factors of patients with pulmonary hypertension can be evaluated and how the treatment plan can be arranged to prevent postoperative complications and reduce postoperative morbidity/mortality rates. We aim to compare the postoperative morbidity/mortality rates and complication frequency of patients who were evaluated and treated preoperatively with those who did not receive treatment.
Measured: 11/2021- 11/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for oPAP Should be > 25mmHg in Right Heart Catheterization at RestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Nemika Gökdemir, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565911
- Sponsor's protocol ID
- 2022-03/1615
- Acronym
- PulmonaryHT
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Postoperative Morbidity / Mortality Rates of Patients With Pulmonary Hypertension With Risk Factors
- ClinicalTrials.gov ID
- NCT05565911
- Acronym / sponsor ID
- PulmonaryHT / 2022-03/1615
- Conditions
- oPAP Should be > 25mmHg in Right Heart Catheterization at Rest, There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery
- Keywords
- pulmonary hypertension, hemodinamic monitorization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
Pulmonary hypertension (PHT) is an oPAP ≥25 mmHg as assessed by right heart catheterization at rest. It is divided into 5 groups according to its etiology and mechanism. The first group is patients with pulmonary arterial hypertension due to various reasons (drugs, connective tissue diseases, etc.). Group 2 is classified as left heart failure, group 3 is due to chronic lung disease and hypoxemia, group 4 is due to pulmonary arterial obstruction (most commonly CTEPH), and group 5 is patients with pulmonary hypertension due to multifactorial unspecified causes.
In the pathophysiology, pulmonary hypertension occurs when the balance is disturbed by endothelial dysfunction, decrease in vasodilator mediators (NO, prostacyclin) and increase in vasoconstrictor mediators (endothelin-1, serotonin, thromboxan) in the vascular bed.
Perioperatively, patients with WHO functional classification >2, right ventricular hypertrophy, obese, chronic renal failure, previous PTE, COPD, diabetes mellitus are more prone to complications related to pulmonary hypertension. Although factors such as emergency surgery, intraoperative vasopressor use, delayed intubation, acidosis, and hyperthermia pave the way for postoperative pulmonary complications, attention should be paid to mortality and morbidity since they are also preventable factors.
Postoperatively, as a result of the supine position triggering bronchospasm with secretions, acute lung injury in addition to the existing comorbidity occurs. With the increase in respiratory workload, acute respiratory failure develops with symptoms such as hypoxemia and hypercarbia. Residual anesthesia, increased pain or prolonged mechanical ventilation time also decrease functional residual capacity, increasing the possibility of atelectasis development.
With the records we kept in our study, we aimed to show which complications the patients with pulmonary hypertension faced after their surgeries due to their underlying diseases and References ESC/ERC Guidelines Eurepean Heart Journal 2016; 37:67-119 Aguirre MA, et al. Advances in Anesthesia 2018;36: 201-30
Detailed description
Our study will be carried out by recording the patients with PHT who underwent non-cardiac and non-obstetric surgeries at Başkent University Ankara Hospital between 11/10/2021 and 11/10/2023. It was planned to select the patients participating in our study on a voluntary basis and to include only the patients who agreed to participate in the study. Informed consent will be obtained by informing the patients before the application.
Both patient groups will be evaluated in the anesthesia polyclinic in the preoperative period. Routine blood tests will be done. It was planned as a cohort study. Depending on the surgery type of the patients, GA or RA will be applied as appropriate. The drugs in the standard anesthesia method will be administered to the patients. Standard monitoring and, if necessary, other invasive monitoring methods will be applied. Echocardiography evaluations, pulmonary function tests will be planned, and control evaluations will be requested at the 3rd, 6th and 1st postoperative months.
By the team in the postoperative recovery unit, hypoventilation (falling below breath per minute), apnea (episodes longer than 10 seconds), hypoxemia (SpO2<90, nasal O2 or Room Air), tachypnea, dyspnea, arrhythmia, chest pain, tachycardia, hypotension 30 minutes in terms of symptoms such as hypertension, laryngospasm, bronchospasm, subcostal retraction. They will be followed throughout. They will be evaluated in terms of analgesia control with Numeric Pain Score.
It will be evaluated in terms of postoperative pulmonary complications (tracheal reintubation) in the recovery unit and afterwards, extubation failure, pulmonary edema, and pneumothorax at the end of the case, and records will be kept.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Araştırma kapsamında pulmoner hipertansiyonu olan hastaların geçirecekleri cerrahilerde kendi hasta popülasyonlarına özel ne gibi risk faktörlerine sahip oldukları, tedavi olan ve olmayanlarda postoperatif komplikasyon gelişme sıklığının araştırılması planlanmaktadır
Key inclusion criteria (2 listed)
- • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB> 25mmHg olan hastalar,
Key exclusion criteria (2 listed)
- • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB< 25mmHg olan hastalar,
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 |
|---|---|---|
| no interventionthis is an observational study, there is no intervention. | Other | – |
Primary outcome
Comparison of postoperative morbidity/mortality
Time frame: 11/2021- 11/2023
In this study, we investigated how the risk factors of patients with pulmonary hypertension can be evaluated and how the treatment plan can be arranged to prevent postoperative complications and reduce postoperative morbidity/mortality rates. We aim to compare the postoperative morbidity/mortality rates and complication frequency of patients who were evaluated and treated preoperatively with those who did not receive treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of oPAP Should be > 25mmHg in Right Heart Catheterization at Rest and There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 4 Oct 2022. 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 Turkey (Türkiye). 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?
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?
Comparison of postoperative morbidity/mortality (time frame: 11/2021- 11/2023). 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 4 Oct 2022.