Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT07207967
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2025-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
End-Inspiratory Pause in COPD Patients During Controlled Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D018467', 'term': 'Positive-Pressure Respiration, Intrinsic'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-09-27', 'studyFirstSubmitQcDate': '2025-09-27', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial pressure of carbon dioxide', 'timeFrame': '30 min', 'description': 'Arterial pressure of carbon dioxide'}, {'measure': 'arterial pH', 'timeFrame': '30 min', 'description': 'arterial pH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'COPD', 'End-inspiratory pause', 'AutoPEEP'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': "In patients with airflow obstruction receiving mechanical ventilation, an important objective is to reduce lung hyperinflation often using controlled hypoventilation\\[1\\]. At the same time, maintaining acceptable gas exchange is challenging, as major reductions in minute ventilation (VE) raises carbon dioxide (CO2) and causes respiratory acidosis, which may lead to adverse physiological consequences.\n\nRelatively prolonged end-inspiratory pause (EIP) has been shown to optimize CO2 clearance in hypoxemic mechanically ventilated patients\\[2\\]. Previous data suggests that, at equivalent total inspiratory-time (TI), shorter insufflations followed by EIP can enhance CO2 elimination in acute lung injury \\[3\\]. Adding EIP is classically discouraged in chronic obstructive pulmonary disease (COPD) because - at constant respiratory rate (RR) - prolonging inspiration reduces expiratory time (TE), and can worsen hyperinflation and impair hemodynamics\\[4, 5\\].\n\nIn this study, we assessed whether a breathing pattern characterized by high inspiratory flow (V ̇) plus EIP could reduce PaCO2 without inducing hyperinflation, compared with same inspiration-to-expiration time (I:E) and a ventilation pattern without EIP in patients with COPD undergoing controlled hypoventilation.\n\nMethods We performed a prospective, single-center, cross-over, randomized trial (ethical approval #10/2024) including deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort. Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria. Patient's next of kin signed the informed consent.\n\nAt inclusion, we collected demographic characteristics and baseline respiratory variables. A CT-emphysema score\\[6\\], using computed tomographies obtained within 24 hs of intubation for clinical reasons, was calculated (A.R, a pulmonologist specialized in medical imaging). Each lung was divided into 3 regions (superior, medium and inferior) based on anatomical references and were graded as no emphysema (score 0), emphysema ≤25% (score 1), ≤50% (score 2), ≤75% (score 3) and \\>75% (score 4). Scores of the six regions were summed to obtain the total score, giving a minimum 0 and a maximum of 24 points. Total scores ≥ 2 are indicative of emphysema.\n\nPatients were ventilated in volume-controlled mode with square-flow waveform, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) was set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP\\[7\\], and FiO2 to maintain oxygen saturation of 90-95%.\n\nTwo ventilation strategies, each one applied for 30 minutes, were randomly evaluated (Figure 1A): a) ventilation without EIP, using initial ventilator settings (VentNO-PAUSE); b) ventilation with EIP (VentPAUSE), in which V ̇ was increased and 40-50% of the total inspiratory time (TI) was replaced by EIP; the remaining setting were equal to VentNO-PAUSE. At the end of each phase, we collected arterial blood gases, respiratory mechanics and basic hemodynamics. Total PEEP (i.e., PEEPtot=PEEPext + autoPEEP) and Pplat were assessed with 5-second end-expiratory, and 2-second end-inspiratory occlusions, respectively. Driving airway pressure (ΔP) was computed as Pplat - PEEPtot, normalized elastance (ERS-n) as driving pressure (ΔP)/VtPBW and inspiratory airway resistance (Raw) as (Peak pressure \\[Ppeak\\] - Pplat) / V ̇.\n\nWe hypothesized that ventilation efficiency would be better during VentPAUSE, and wanted to evaluate whether this strategy would have allowed to reduce VE while keeping the same CO2 obtained without EIP. Accordingly, and assuming a constant CO2 production, we calculated the predicted VE during VentPAUSE to maintain the same CO2 measured during VentNO-PAUSE with the formula :\n\nPredicted VE\\_( (Vent\\_PAUSE))=█(〖PaCO\\_(2 )〗\\_((Vent\\_PAUSE ) )@ )/〖PaCO\\_2〗\\_((Vent\\_(NO-PAUSE) ) ) × VE used during the study phases \\[8\\] This allowed to calculate to what extent it would have been possible to reduce VE (VEpred) and RR (RRpred) using the experimental strategy. We additionally calculated the predicted prolongation of expiration using the new RRpred as: TE-pred = (60/RRpred) - TI.\n\nWe calculated the ventilatory ratio as an indice reflecting physiological dead-space ventilation (VD/VT)\\[9\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort\n* sign the informed consent\n\nExclusion Criteria:\n\n* Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07207967', 'acronym': 'PYE', 'briefTitle': 'End-Inspiratory Pause in COPD Patients During Controlled Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Sanatorio Anchorena San Martin'}, 'officialTitle': 'End-Inspiratory Pause Enhances Ventilation Efficiency Without Affecting autoPEEP in COPD Patients During Controlled Ventilation', 'orgStudyIdInfo': {'id': '10/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NO PAUSE ventilation', 'description': 'Patients will be ventilated in volume-controlled mode with square-flow waveform, without end-inspiratory pause, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%.', 'interventionNames': ['Other: NO PAUSE VENTILATION']}, {'type': 'EXPERIMENTAL', 'label': 'PAUSE ventilation', 'description': 'Patients will be ventilated in volume-controlled mode with square-flow waveform, where total Ti will be the same that during NO PAUSE ventilation, but inspiratory flow will be increased and a part of the total inspiratory time will be replaced by end-inspiratory pause of 0.3-0.5 s. All the remaining parameters will be equal to the NO PAUSE ventilation phase. Tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%.', 'interventionNames': ['Other: END INSPIRATORY PAUSE DURING CONTROLLED VENTILATION']}], 'interventions': [{'name': 'END INSPIRATORY PAUSE DURING CONTROLLED VENTILATION', 'type': 'OTHER', 'description': 'PATIENTS WILL BE VENTILATED WITH END-INSPIRATORY PAUSE AND HIGH INSPIRATORY FLOW DURING CONTROLED VENTILATION', 'armGroupLabels': ['PAUSE ventilation']}, {'name': 'NO PAUSE VENTILATION', 'type': 'OTHER', 'description': 'PATIENTS WILL BE VENTILATED IN VOLUME CONTROLLED VENTILATION WITHOUT END-INSPIRATORY PAUSE', 'armGroupLabels': ['NO PAUSE ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1650', 'city': 'San Martín', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio Anchorena San Martín', 'geoPoint': {'lat': -35.02575, 'lon': -57.75317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'confidential data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanatorio Anchorena San Martin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Joaquin Pérez', 'investigatorFullName': 'Matias Accoce', 'investigatorAffiliation': 'Sanatorio Anchorena San Martin'}}}}