Obesity Associated DisorderRespiratoryNCT05508997

Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

A study testing respiratory parameters on mechanical ventilator (PEEP) in people with Obesity Associated Disorder, run by Heidy F. Ahmed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Obesity Associated Disorder
What is being tested?: respiratory parameters on mechanical ventilator (PEEP)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Dec 2021to 30 Jun 2022
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 40 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects included in this study had the following criteria:
Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
Obese patients with BMI (30-34.9).
Age 40-50 years old.
Both sexes.
Non-smoker.
No history of disease affecting the heart \& lungs.

Who cannot join

Subjects with any of the following were excluded from the study:
Severe head injury.
Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
Acute pulmonary edema.
Barotrauma/volutrauma.
Un-drained Pneumothorax/Hemothorax.

Show all 9Show fewer

Flail chest.
Low blood pressure (systolic less than 80 mmHg).
Oxygen saturation is less than 90%.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Al Kasr Al Aini Teaching Hospital
Giza, 12556

Other trials in Egypt

About this study

Official title: Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP\& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) \& mean arterial blood pressure (MAP) were recorded.

Read the detailed description

Objective To investigate the effect of the positive end-expiratory pressure (PEEP) titration maneuver with Reverse Trendelenburg Position (RTP) on the respiratory and hemodynamic parameters of mechanically ventilated obese patients.

Design Randomized, control trial. Participants Thirty mechanically ventilated obese patients were randomized equally as a group A to receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Intervention After post-operative bariatric surgeries, the sixty mechanically ventilated obese patients immediately receive a PEEP and RTP once before the weaning through the ventilator of the operation to evaluate the response of arterial blood gases before admission to the intensive care unit ICU room.

Outcomes The primary outcomes included the respiratory parameters (PaO2/FiO2 ratio, PaCO2, Cstat), and the secondary outcomes included the hemodynamics parameters (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)).

Conditions: Obesity Associated Disorder
Being tested: respiratory parameters on mechanical ventilator (PEEP)
Keywords: Positive end-expiratory pressure titration, Mechanical ventilator, respiratory and hemodynamics parameters, Obese patients, Reverse Trendelenburg Position.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

respiratory parameters on mechanical ventilator (PEEP)Device
The 3rd \& 4th phases of operation in the group (A) and (B): Each patient received one single session inside the Operation Room (OR) as one shot of the treatment procedure. Arterial Blood Gases (ABGs) were obtained to measure:
1. Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome.
2. Secondary outcome.
- Ventilation by PaCO2 value from ABGs.
- Static compliance (Cstat) was measured as the amount of recruitment of alveoli in the lung.
- Blood pressure (systolic/diastolic) one of the hemodynamics measurements was measured pre/post the procedure in the two groups.

Study groups in NCT05508997
Study group	Role	What they receive
Positive End Expiatory Pressure + Reverse Trendelenburg Position	Experimental	Group A received the procedures of the physiotherapy part by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), which is the patient laid supine with the head up 30 degrees higher than the feet \& received the recruitment maneuver (RM) by Positive End Expiratory Pressure (PEEP) titration Receives: Device: respiratory parameters on mechanical ventilator (PEEP)
Reverse Trendelenburg Position	Active comparator	Group B received only the procedures of the physiotherapy part at the 3rd phase of operation by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), in which the patient laid supine with the head at 15-30 degrees higher than the feet to unload the weight of intra-abdominal contents from the diaphragm, this position: 1. Increase pulmonary compliance, functional residual capacity (FRC), and oxygenation. 2. Allows easier ventilation. 3. This position called safe apnea time allows time to secure the airway before desaturation for a 20-minute positioning time. Receives: Device: respiratory parameters on mechanical ventilator (PEEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory parameters
The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio
Measured: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.

Secondary outcomes (1)

Hemodynamics parameters
The secondary outcomes included the hemodynamics parameters (SBP in mmHg, DBP in mmHg, and MAP in mmHg).
Measured: Immediately after the procedure is done in the operating room appears on the patient's monitor.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202130 Jun 2022

First posted19 Aug 2022
Study start1 Dec 2021
Primary completion17 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Obesity Associated DisorderStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: group A receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05508997
Sponsor's protocol ID: P.T.REC/012/001827
Acronym: Respiratory
Status last verified: Feb 2023
First submitted: 11 Aug 2022
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected individual participant data (IPD), all IPD that underlie results in a publication.

Publications

Hibbert KA, Malhotra A. Obesity in Critically Ill Patients. In Cardiopulmonary Monitoring. 2021 (pp. 935-947). Springer, Cham. https://doi.org/10.1007/978-3-030-73387-2
Wang QY, Ji YW, An LX, Cao L, Xue FS. Effects of individualized PEEP obtained by two different titration methods on postoperative atelectasis in obese patients: study protocol for a randomized controlled trial. Trials. 2021 Oct 15;22(1):704. doi: 10.1186/s13063-021-05671-1.
PubMed 34654446
Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Muller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.
PubMed 28454590
Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.
PubMed 32388650
Silva PL, Pelosi P, Rocco PR. Ventilation in the Obese Patient. In Mechanical Ventilation from Pathophysiology to Clinical Evidence. 2022 (pp. 223-229). Springer, Cham. http://doi.org/10.1007/978-3-030-93401-9
Bruins S, Sommerfield D, Powers N, von Ungern-Sternberg BS. Atelectasis and lung recruitment in pediatric anesthesia: An educational review. Paediatr Anaesth. 2022 Feb;32(2):321-329. doi: 10.1111/pan.14335. Epub 2021 Nov 24.
PubMed 34797011
Brodsky JB. Recent advances in anesthesia of the obese patient. F1000Res. 2018 Aug 6;7:F1000 Faculty Rev-1195. doi: 10.12688/f1000research.15093.1. eCollection 2018.
PubMed 30135720
De Jong A, Wrigge H, Hedenstierna G, Gattinoni L, Chiumello D, Frat JP, Ball L, Schetz M, Pickkers P, Jaber S. How to ventilate obese patients in the ICU. Intensive Care Med. 2020 Dec;46(12):2423-2435. doi: 10.1007/s00134-020-06286-x. Epub 2020 Oct 23.
PubMed 33095284
Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.
PubMed 33137453
Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O'Gara BP, Talmor DS. The Effect of Positive End-Expiratory Pressure on Intracranial Pressure and Cerebral Hemodynamics. Neurocrit Care. 2017 Apr;26(2):174-181. doi: 10.1007/s12028-016-0328-9.
PubMed 27848125
Fumagalli J, Santiago RRS, Teggia Droghi M, Zhang C, Fintelmann FJ, Troschel FM, Morais CCA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. Lung Recruitment in Obese Patients with Acute Respiratory Distress Syndrome. Anesthesiology. 2019 May;130(5):791-803. doi: 10.1097/ALN.0000000000002638.
PubMed 30844949
Zhu C, Yao JW, An LX, Bai YF, Li WJ. Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial. Trials. 2020 Jul 6;21(1):618. doi: 10.1186/s13063-020-04565-y.
PubMed 32631414
Eichler L, Truskowska K, Dupree A, Busch P, Goetz AE, Zollner C. Intraoperative Ventilation of Morbidly Obese Patients Guided by Transpulmonary Pressure. Obes Surg. 2018 Jan;28(1):122-129. doi: 10.1007/s11695-017-2794-3.
PubMed 28707173
Lutfi MF. The physiological basis and clinical significance of lung volume measurements. Multidiscip Respir Med. 2017 Feb 9;12:3. doi: 10.1186/s40248-017-0084-5. eCollection 2017.
PubMed 28194273
Moon TS, Tai K, Kim A, Gonzales MX, Lu R, Pak T, Smith K, Chen JL, Minhajuddin AT, Nnamani N, Fox PE, Ogunnaike B. Apneic Oxygenation During Prolonged Laryngoscopy in Obese Patients: a Randomized, Double-Blinded, Controlled Trial of Nasal Cannula Oxygen Administration. Obes Surg. 2019 Dec;29(12):3992-3999. doi: 10.1007/s11695-019-04077-y.
PubMed 31317460

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05508997
Acronym / sponsor ID: Respiratory / P.T.REC/012/001827
Conditions: Obesity Associated Disorder
Keywords: Positive end-expiratory pressure titration, Mechanical ventilator, respiratory and hemodynamics parameters, Obese patients, Reverse Trendelenburg Position.
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Heidy F. AhmedUniversity, hospital or other
Study start: 1 Dec 2021 (actual)
Primary completion: 17 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 19 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: group A receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Arm	Type	Receives
Positive End Expiatory Pressure + Reverse Trendelenburg Position	Experimental	Device: respiratory parameters on mechanical ventilator (PEEP)Group A received the procedures of the physiotherapy part by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), which is the patient laid supine with the head up 30 degrees higher than the feet \& received the recruitment maneuver (RM) by Positive End Expiratory Pressure (PEEP) titration
Reverse Trendelenburg Position	Active comparator	Device: respiratory parameters on mechanical ventilator (PEEP)Group B received only the procedures of the physiotherapy part at the 3rd phase of operation by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), in which the patient laid supine with the head at 15-30 degrees higher than the feet to unload the weight of intra-abdominal contents from the diaphragm, this position: 1. Increase pulmonary compliance, functional residual capacity (FRC), and oxygenation. 2. Allows easier ventilation. 3. This position called safe apnea time allows time to secure the airway before desaturation for a 20-minute positioning time.

Who may qualify

Ages: 40 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Subjects included in this study had the following criteria:

Key exclusion criteria (9 listed)

Subjects with any of the following were excluded from the study:

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
respiratory parameters on mechanical ventilator (PEEP)The 3rd \& 4th phases of operation in the group (A) and (B): Each patient received one single session inside the Operation Room (OR) as one shot of the treatment procedure. Arterial Blood Gases (ABGs) were obtained to measure: 1. Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome. 2. Secondary outcome. * Ventilation by PaCO2 value from ABGs. * Static compliance (Cstat) was measured as the amount of recruitment of alveoli in the lung. * Blood pressure (systolic/diastolic) one of the hemodynamics measurements was measured pre/post the procedure in the two groups.	Device	Positive End Expiatory Pressure + Reverse Trendelenburg Position, Reverse Trendelenburg Position

Primary outcome

Respiratory parameters
Time frame: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.
The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio

1 secondary outcome

Hemodynamics parameters
Time frame: Immediately after the procedure is done in the operating room appears on the patient's monitor.

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 15 Feb 2023.
BackgroundHibbert KA, Malhotra A. Obesity in Critically Ill Patients. In Cardiopulmonary Monitoring. 2021 (pp. 935-947). Springer, Cham. https://doi.org/10.1007/978-3-030-73387-2
Background: PubMed 34654446Wang QY, Ji YW, An LX, Cao L, Xue FS. Effects of individualized PEEP obtained by two different titration methods on postoperative atelectasis in obese patients: study protocol for a randomized controlled trial. Trials. 2021 Oct 15;22(1):704. doi: 10.1186/s13063-021-05671-1.
Background: PubMed 28454590Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Muller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.
Background: PubMed 32388650Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.
BackgroundSilva PL, Pelosi P, Rocco PR. Ventilation in the Obese Patient. In Mechanical Ventilation from Pathophysiology to Clinical Evidence. 2022 (pp. 223-229). Springer, Cham. http://doi.org/10.1007/978-3-030-93401-9
Background: PubMed 34797011Bruins S, Sommerfield D, Powers N, von Ungern-Sternberg BS. Atelectasis and lung recruitment in pediatric anesthesia: An educational review. Paediatr Anaesth. 2022 Feb;32(2):321-329. doi: 10.1111/pan.14335. Epub 2021 Nov 24.
Background: PubMed 30135720Brodsky JB. Recent advances in anesthesia of the obese patient. F1000Res. 2018 Aug 6;7:F1000 Faculty Rev-1195. doi: 10.12688/f1000research.15093.1. eCollection 2018.
Background: PubMed 33095284De Jong A, Wrigge H, Hedenstierna G, Gattinoni L, Chiumello D, Frat JP, Ball L, Schetz M, Pickkers P, Jaber S. How to ventilate obese patients in the ICU. Intensive Care Med. 2020 Dec;46(12):2423-2435. doi: 10.1007/s00134-020-06286-x. Epub 2020 Oct 23.
Background: PubMed 33137453Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.
Background: PubMed 27848125Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O'Gara BP, Talmor DS. The Effect of Positive End-Expiratory Pressure on Intracranial Pressure and Cerebral Hemodynamics. Neurocrit Care. 2017 Apr;26(2):174-181. doi: 10.1007/s12028-016-0328-9.
Background: PubMed 30844949Fumagalli J, Santiago RRS, Teggia Droghi M, Zhang C, Fintelmann FJ, Troschel FM, Morais CCA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. Lung Recruitment in Obese Patients with Acute Respiratory Distress Syndrome. Anesthesiology. 2019 May;130(5):791-803. doi: 10.1097/ALN.0000000000002638.
Background: PubMed 32631414Zhu C, Yao JW, An LX, Bai YF, Li WJ. Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial. Trials. 2020 Jul 6;21(1):618. doi: 10.1186/s13063-020-04565-y.
Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), all IPD that underlie results in a publication.

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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.

Heidy F. Ahmed, Master principal investigator

Kasr al aini

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing respiratory parameters on mechanical ventilator (PEEP) in people with Obesity Associated Disorder, run by Heidy F. Ahmed at 1 site in Egypt.

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 7 inclusion and 9 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 15 Feb 2023. 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 Egypt. 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?

Respiratory parameters (time frame: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508997, which also lists 23 linked publications.

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 15 Feb 2023.