Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06060366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-23
Brief Title:
Impact of Pulmonary Endarterectomy on Sleep-Related Breathing Disorders in CTEPH The IPES Trial
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Impact of Pulmonary Endarterectomy on Sleep-Related Breathing Disorders and Mortality in Chronic Thromboembolic Pulmonary Hypertension - The IPES Trial A Prospective Observational Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPES
Brief Summary:
Pulmonary hypertension PH has three main types pre-capillary PH post-capillary PH and combined pre-capillary and post-capillary PH and it is based on mean pulmonary arterial pressure PAP 20 mmHg measured with a right heart catheterization RHC
Chronic thromboembolic pulmonary hypertension CTEPH is mainly defined as a pre-capillary PH and classed as a Group IV PH It was reported that 01-91 of individuals with pulmonary embolism develop CTEPH within two years after the initial diagnosis and CTEPH is the only PH category that has a chance of being cured mainly by pulmonary endarterectomy
Sleep-related breathing disorders SRBD are defined as obstructive sleep apnea OSA disorders central sleep apnea CSA syndromes sleep-related hypoventilation disorders and sleep-related hypoxemia
An SRBD may also lead to an increase in PAP primarily during sleep and cause nocturnal hypoxemia Although SRBDs were reported in patients with pre-capillary PH most of the studies included patients with idiopathic PAH Although the cause-and-effect relationship between pre-capillary PH and SRBDs is uncertain it is known that mPAP may increase during sleep in patients with OSA
Less is known regarding the occurrence of SRBDs in CTEPH Previously a few study showed relationship between SRBDs an CTEPH as the main type was OSA Most of the studies evaluated preoperative occurance and incidance of SRBDs in CTEPH Only one study performed post operative SRBD on a cardiorespiratory device was conducted the night before and one month after elective pulmonary endarterectomy
In our previous study we showed that severe nocturnal hypoxemia NH is highly prevelant in preoperative CTEPH patients and the most common two types of SRBD are OSA and isolated sleep related hypoxemia ISRH and age mPAP and AHI are independent determinants of severe NH J Clin Med 2023 12 4639 httpsdoiorg103390jcm12144639 In this present study we aimed to investigate occurrence of SRBDs and mortality 5 years after pulmonary endarterectomy operation
Chronic thromboembolic pulmonary hypertension CTEPH is mainly defined as a pre-capillary PH and classed as a Group IV PH It was reported that 01-91 of individuals with pulmonary embolism develop CTEPH within two years after the initial diagnosis and CTEPH is the only PH category that has a chance of being cured mainly by pulmonary endarterectomy
Sleep-related breathing disorders SRBD are defined as obstructive sleep apnea OSA disorders central sleep apnea CSA syndromes sleep-related hypoventilation disorders and sleep-related hypoxemia
An SRBD may also lead to an increase in PAP primarily during sleep and cause nocturnal hypoxemia Although SRBDs were reported in patients with pre-capillary PH most of the studies included patients with idiopathic PAH Although the cause-and-effect relationship between pre-capillary PH and SRBDs is uncertain it is known that mPAP may increase during sleep in patients with OSA
Less is known regarding the occurrence of SRBDs in CTEPH Previously a few study showed relationship between SRBDs an CTEPH as the main type was OSA Most of the studies evaluated preoperative occurance and incidance of SRBDs in CTEPH Only one study performed post operative SRBD on a cardiorespiratory device was conducted the night before and one month after elective pulmonary endarterectomy
In our previous study we showed that severe nocturnal hypoxemia NH is highly prevelant in preoperative CTEPH patients and the most common two types of SRBD are OSA and isolated sleep related hypoxemia ISRH and age mPAP and AHI are independent determinants of severe NH J Clin Med 2023 12 4639 httpsdoiorg103390jcm12144639 In this present study we aimed to investigate occurrence of SRBDs and mortality 5 years after pulmonary endarterectomy operation
Detailed Description:
This study planned as continuation study of Determinants of severe nocturnal hypoxemia in adults with chronic thromboembolic pulmonary hypertension and sleep related breathing disorders J Clin Med 2023 12 4639 httpsdoiorg103390jcm12144639
Previously included patients 50 patients who were referred for pulmonary endarterectomy operation between 5 May 2017 and 7 February 2018
All participants underwent a computerized pulmonary angiography and RHC after that mismatch of perfusion defects detected in ventilationperfusion scintigraphy VQ despite 3 months of anticoagulant therapy
Patients with an mPAP 20 mmHg measured with RHC were accepted having CTEPH PAWP15mmHg and PVR 3 Wood Units were additional measurements suggestive of CTEPH
Eligible for surgery
Appropriate polisomnography test before surgery
Total sleep time should be 4 hours planned to include current study
1 Demographic data body mass index BMI comorbid conditions medications supplementary oxygen treatment preoperative echocardiography findings RHC measurements 6 min walk distance SMWD pulmonary function test as well as carbon monoxide diffusion test DLCO measurements will be recorded
MIR Spirolab II spirometry Medical International Research Rome Italy was used to test pulmonary function including forced expiratory volume in one second FEV1 and forced vital capacity FVC diffusing capacity of the lung for DLCO in a body plethsmograph CareFusion Type MasterScreen PFT Hoechberg Germany and performance of an SMWD All results were assessed in accordance with ATS recommendations
2 A polisomnography test will perfomed to all participants whether had pulmonary endarterectomy operation or followed up by medical treatment
All patients will hospitalized for polysomnographic monitoring using the NOX- A1 system Nox Medical Inc Reykjavik Iceland The PSG recording included an elec- troencephalogram F4M1 F3M2 C4M1 C3M2 O2M1 O1M2 electro-oculogram submental and tibialis electromyograms as well as an electrocardiogram Ventilatory monitoring included a nasal pressure detector using a nasal cannulapressure transducer system and thoracoabdominal movement detection through two respiratory inductance plethysmography belts A finger pulse oximeter detecting heart rate SpO2 as well as body position and movement detection will also include Participants with a total sleep time of less than 4 h will be offered a new PSG Sleep stages and arousals will score based on 30 s epochs in accordance with The AASM Manual for the Scoring of Sleep and Associated Events 25 published by the American Academy of Sleep Medicine AASM independently of the patients clinics by a certified sleep physician Apnea will define as an almost complete 90 cessation of airflow and hypopnea will define as a decrease in nasal pressure amplitude of 30 or more andor thoraco-abdominal movement of at least 30 for at least 10 s if there will be a significant oxyhemoglobin desaturation reduction of at least 3 from the immediately preceding baseline value andor arousal according to the latest recommendations of the AASM
SRBDs defined according to the International Classification of Sleep Disorders ICSD-10 as obstructive sleep apnea OSA as an AHI 15 eventsh central sleep apnea with Cheyne-Stokes respiration CSA-CSR CSR pattern 50 of total sleep time with TST obesity hypoventilation syndrome OHS and isolated sleep-related hypoxemia ISRH nocturnal oxyhemoglobin saturation SpO2 88 for 5 min or more without OSA CSA or OHS Severe NH was defined as SpO2 90 for more than 20 of total sleep time TST
3 Cardiac evaluation will be performed by transthoracic-echocardiography TTE TTE based on the guidelines of the device Epiq 7 Philips Healthcare Andover MA USA with a 35 MHz S5-1 transducer Digitally stored images will analyze offline Xcelera Philips Based on the guidelines the systolic and diastolic characteristics of the left and right heart will measure as recommended Tricuspid regurgitation velocity and other echocardiographic signs will combine to assess the probability of PH as recommended in ERS guidelines
Previously included patients 50 patients who were referred for pulmonary endarterectomy operation between 5 May 2017 and 7 February 2018
All participants underwent a computerized pulmonary angiography and RHC after that mismatch of perfusion defects detected in ventilationperfusion scintigraphy VQ despite 3 months of anticoagulant therapy
Patients with an mPAP 20 mmHg measured with RHC were accepted having CTEPH PAWP15mmHg and PVR 3 Wood Units were additional measurements suggestive of CTEPH
Eligible for surgery
Appropriate polisomnography test before surgery
Total sleep time should be 4 hours planned to include current study
1 Demographic data body mass index BMI comorbid conditions medications supplementary oxygen treatment preoperative echocardiography findings RHC measurements 6 min walk distance SMWD pulmonary function test as well as carbon monoxide diffusion test DLCO measurements will be recorded
MIR Spirolab II spirometry Medical International Research Rome Italy was used to test pulmonary function including forced expiratory volume in one second FEV1 and forced vital capacity FVC diffusing capacity of the lung for DLCO in a body plethsmograph CareFusion Type MasterScreen PFT Hoechberg Germany and performance of an SMWD All results were assessed in accordance with ATS recommendations
2 A polisomnography test will perfomed to all participants whether had pulmonary endarterectomy operation or followed up by medical treatment
All patients will hospitalized for polysomnographic monitoring using the NOX- A1 system Nox Medical Inc Reykjavik Iceland The PSG recording included an elec- troencephalogram F4M1 F3M2 C4M1 C3M2 O2M1 O1M2 electro-oculogram submental and tibialis electromyograms as well as an electrocardiogram Ventilatory monitoring included a nasal pressure detector using a nasal cannulapressure transducer system and thoracoabdominal movement detection through two respiratory inductance plethysmography belts A finger pulse oximeter detecting heart rate SpO2 as well as body position and movement detection will also include Participants with a total sleep time of less than 4 h will be offered a new PSG Sleep stages and arousals will score based on 30 s epochs in accordance with The AASM Manual for the Scoring of Sleep and Associated Events 25 published by the American Academy of Sleep Medicine AASM independently of the patients clinics by a certified sleep physician Apnea will define as an almost complete 90 cessation of airflow and hypopnea will define as a decrease in nasal pressure amplitude of 30 or more andor thoraco-abdominal movement of at least 30 for at least 10 s if there will be a significant oxyhemoglobin desaturation reduction of at least 3 from the immediately preceding baseline value andor arousal according to the latest recommendations of the AASM
SRBDs defined according to the International Classification of Sleep Disorders ICSD-10 as obstructive sleep apnea OSA as an AHI 15 eventsh central sleep apnea with Cheyne-Stokes respiration CSA-CSR CSR pattern 50 of total sleep time with TST obesity hypoventilation syndrome OHS and isolated sleep-related hypoxemia ISRH nocturnal oxyhemoglobin saturation SpO2 88 for 5 min or more without OSA CSA or OHS Severe NH was defined as SpO2 90 for more than 20 of total sleep time TST
3 Cardiac evaluation will be performed by transthoracic-echocardiography TTE TTE based on the guidelines of the device Epiq 7 Philips Healthcare Andover MA USA with a 35 MHz S5-1 transducer Digitally stored images will analyze offline Xcelera Philips Based on the guidelines the systolic and diastolic characteristics of the left and right heart will measure as recommended Tricuspid regurgitation velocity and other echocardiographic signs will combine to assess the probability of PH as recommended in ERS guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None