Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome.

NCT05405335 | Completed

• 1 other identifier: AyubMC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and for suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed covid pneumonia admitted in the covid wards.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Pneumonia; Prone Positioning

Outcome Measures

Primary Outcomes (1)

• percentage of patients dying COVID-19 pneumonia/ ARDS in both groups

  Effect of prone positioning on the mortality of patients suffering from covid pneumonia/ acute respiratory distress syndrome

  Three months

Secondary Outcomes (1)

• Respiratory physiology- mean PaO2 and Mean respiratory rate of both groups at first, seventh and fiourteenth day of admission

  Three months

Study Arms (2)

Prone Positioned Group

EXPERIMENTAL

Intermittent prone positioning for a total of eight hours per day for seven days. Each cycle of prone positioning should not be less than 30 minutes and note more than 3 hours at one time. Rest of the treatment as per protocols of the institution

Other: Prone Positioning Maneuver

Control Group

NO INTERVENTION

Treatment as per institutional protocols- the protocols does not involve prone positioning of the patients

Interventions

Prone Positioning Maneuver OTHER

intermittent prone positioning for eight hours per day for seven days. each cycle should not be less than 30 minutes or more than 3 hours.

Also known as: Prone Positioning

Prone Positioned Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed covid pneumonia/ acute respiratory distress syndrome cases

You may not qualify if:

• consent denial, patients having contraindications to prone positioning such as shock, acute bleeding, trauma, spinal instability, raised Intracranial Pressure, sternal/ tracheal surgery, Female pregnant patients in 2nd and 3rd trimester

Sponsors & Collaborators

• Ayub Medical College, Abbottabad: lead
• Ayub Teaching Hospital: collaborator

Study Sites (1)

Ayub Teaching Hospital

Abbottābād, KPK, 22040, Pakistan

Location

Related Publications (2)

• Johnson SA, Horton DJ, Fuller MJ, Yee J, Aliyev N, Boltax JP, Chambers JH, Lanspa MJ. Patient-directed Prone Positioning in Awake Patients with COVID-19 Requiring Hospitalization (PAPR). Ann Am Thorac Soc. 2021 Aug;18(8):1424-1426. doi: 10.1513/AnnalsATS.202011-1466RL. No abstract available.

  PMID: 33596394 BACKGROUND

• Oliveira VM, Weschenfelder ME, Deponti G, Condessa R, Loss SH, Bairros PM, Hochegger T, Daroncho R, Rubin B, Chiste M, Batista DC, Bassegio DM, Nauer Wda S, Piekala DM, Minossi SD, Santos VF, Victorino J, Vieira SR. Good practices for prone positioning at the bedside: Construction of a care protocol. Rev Assoc Med Bras (1992). 2016 May-Jun;62(3):287-93. doi: 10.1590/1806-9282.62.03.287.

  PMID: 27310555 BACKGROUND

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hamza Javed, MBBS

  Ayub Teaching Hospital, ABbottabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: parallel groups randomized clinical trial

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 6, 2022
• Study Start: October 15, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)