NCT04566419: SAMURAI

poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence

Completed NA Last updated 16 September 2022

What this trial tests

NA trial testing HFNC - Airvo 2 in Pulmonary Atelectasis in 80 participants. Completed in 1 June 2022.

Timeline

1 October 2020

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 October 2020
Primary completion	1 June 2022
Estimated completion	1 June 2022
Sites	1 location across Italy

Drugs / interventions tested

• HFNC - Airvo 2
• Oxygen — full drug profile →

Conditions studied

• Pulmonary Atelectasis — all drugs for Pulmonary Atelectasis →
• Postoperative Complications — all drugs for Postoperative Complications →
• Gynecologic Cancer — all drugs for Gynecologic Cancer →
• Anesthesia — all drugs for Anesthesia →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Pulmonary Atelectasis or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.

Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered.

Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked.

The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a pre-emptive 2-hour session of high-flow nasal oxygen on postoperative oxygenation after major gynaecologic surgery: a randomised clinical trial.
   Frassanito L, Grieco DL, Zanfini BA, Catarci S, et al · · 2023 · cited 13× · PMID 37543437 · DOI 10.1016/j.bja.2023.07.002